Newly Added Recommendations (count 16 new) |
Active Ingredient
(link to Specific Guidance) |
Type |
Route of Administration |
Dosage Form |
RLD
Application Number
(link to Orange Book) |
Date
Recommended |
|
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate |
Draft |
Oral |
Tablet |
11522 |
12/2008 |
Azithromycin |
Draft |
Oral |
Suspension |
50710 |
12/2008 |
Chlorpheniramine Polistirex; Hydrocodone Polistirex |
Draft |
Oral |
Capsule, Extended Release |
77273 |
12/2008 |
Dextroamphetamine Sulfate |
Draft |
Oral |
Capsule, Extended Release |
17078 |
12/2008 |
Dextromethorphan Hydrobromide; Guaifenesin |
Draft |
Oral |
Tablet, Extended Release |
21620 |
12/2008 |
Famotidine |
Draft |
Oral |
Suspension |
19527 |
12/2008 |
Fexofenadine HCl |
Draft |
Oral |
Suspension |
21963 |
12/2008 |
Guaifenesin; Pseudoephedrine HCl |
Draft |
Oral |
Tablet, Extended Release |
21585 |
12/2008 |
Haloperidol |
Draft |
Oral |
Tablet |
71206
71207
71208
71209
71210
71211 |
12/2008 |
Lovastatin; Niacin |
Draft |
Oral |
Tablet, Extended Release |
21249 |
12/2008 |
Mycophenolic Acid |
Draft |
Oral |
Tablet, Delayed Release |
50791 |
12/2008 |
Pramipexole Dihydrochloride |
Draft |
Oral |
Tablet |
20667 |
12/2008 |
Temozolomide |
Draft |
Oral |
Capsule |
21029 |
12/2008 |
Trandolapril; Verapamil HCl |
Draft |
Oral |
Tablet, Extended Release |
20591 |
12/2008 |
Vancomycin HCl
|
Draft |
Oral |
Capsule |
50606 |
12/2008 |
|
Individual Recommendations (count 400)
|
Active Ingredient
(link to Specific Guidance) |
Type |
Route of Administration |
Dosage Form |
RLD Application Number (link to Orange Book) |
Date
Recommended |
A |
Abacavir Sulfate |
Final |
Oral |
Tablet |
20977 |
5/2008 |
Abacavir Sulfate; Lamivudine |
Draft |
Oral |
Tablet |
21652 |
11/2007 |
Abacavir Sulfate; Lamivudine; Zidovudine |
Final |
Oral |
Tablet |
21205 |
5/2008 |
Acamprosate Calcium |
Final |
Oral |
Tablet, Delayed Release |
21431 |
5/2008 |
Acetazolamide |
Draft |
Oral |
Tablets |
40195 |
7/2008 |
Acitretin |
Draft |
Oral |
Capsule |
19821 |
5/2007 |
Acyclovir |
Final |
Oral |
Tablet |
20089 |
5/2008 |
Adefovir Dipivoxil |
Draft |
Oral |
Tablet |
21449 |
7/2008 |
Albuterol Sulfate |
Draft |
Oral |
Tablet |
72894 |
8/2008 |
Alendronate Sodium |
Draft |
Oral |
Tablet |
20560 |
1/2008 |
Alfuzosin HCl |
Draft |
Oral |
Tablet, Extended Release |
21287 |
11/2007 |
Aliskiren Hemifumarate |
Draft |
Oral |
Tablet |
21985 |
8/2008 |
Almotriptan Malate |
Final |
Oral |
Tablet |
21001 |
5/2008 |
Alosetron HCl |
Final |
Oral |
Tablet |
21107 |
5/2008 |
Alprazolam |
Draft |
Oral |
Tablet, Orally Disintegrating |
21726 |
9/2008 |
Alprazolam |
Draft |
Oral |
Tablet, Extended Release |
21434 |
11/2007 |
Alprazolam
|
Draft |
Oral |
Tablet |
18276 |
9/2008 |
Aminosalicylic Acid |
Draft |
Oral |
Granules, Delayed Release |
74346 |
7/2008 |
Amlodipine Besylate |
Final |
Oral |
Tablet |
19787 |
5/2008 |
Amlodipine Besylate; Benazepril HCl |
Final |
Oral |
Tablet |
20364 |
5/2008 |
Amlodipine Besylate; Olmesartan Medoxomil |
Draft |
Oral |
Tablet |
22100 |
10/2008 |
Amlodipine Besylate; Valsartan |
Draft |
Oral |
Tablet |
21990 |
8/2008 |
Amoxicillin; Clavulanate Potassium |
Draft |
Oral |
Tablet, Chewable |
50597 |
1/2008 |
Amoxicillin; Clavulanate Potassium |
Draft |
Oral |
Tablet, Chewable |
50726 |
1/2008 |
Amoxicillin; Clavulanate Potassium |
Final |
Oral |
Suspension |
50755
50725 |
5/2008 |
Amprenavir |
Draft |
Oral |
Capsule |
21007 |
8/2008 |
Anagrelide HCl |
Final |
Oral |
Capsule |
76468 |
5/2008 |
Anastrozole |
Final |
Oral |
Tablet |
20541 |
5/2008 |
Aprepitant |
Final |
Oral |
Capsule |
21549 |
5/2008 |
Aripiprazole |
Draft |
Oral |
Tablet |
21436 |
11/2007 |
Armodafinil |
Draft |
Oral |
Tablet |
21875 |
1/2008 |
Atazanavir Sulfate |
Final |
Oral |
Capsule |
21567 |
5/2008 |
Atomoxetine HCl |
Final |
Oral |
Capsule |
21411 |
5/2008 |
Atorvastatin Calcium |
Final |
Oral |
Tablet |
20702 |
5/2008 |
Atovaquone |
Draft |
Oral |
Tablet |
20259 |
11/2007 |
Atovaquone; Proguanil |
Draft |
Oral |
Tablet |
21078 |
7/2008 |
Azacitidine |
Draft |
Oral |
Injection |
50794 |
8/2008 |
Azithromycin |
Draft |
Oral |
Suspension, Extended Release |
50797 |
7/2008 |
Azithromycin |
Draft |
Oral |
Tablet |
50730
50711
50784 |
1/2008 |
B |
Baclofen |
Draft |
Oral |
Tablet, Orally Disintegrating |
21589 |
7/2008 |
Balsalazide Disodium |
Draft |
Oral |
Capsule |
20610 |
1/2008 |
Benzonatate |
Final |
Oral |
Capsule |
11210 |
5/2008 |
Benzphetamine HCl |
Final |
Oral |
Capsule |
12427 |
5/2008 |
Bethanechol Chloride |
Draft |
Oral |
Tablet |
88440
88441
89096
89095
|
9/2008 |
Bicalutamide |
Final |
Oral |
Tablet |
20498 |
5/2008 |
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline HCl |
Draft |
Oral |
Capsule |
50786 |
9/2008 |
Bisoprolol Fumarate |
Final |
Oral |
Tablet |
19982 |
5/2008 |
Bisoprolol Fumarate; Hydrochlorothiazide |
Final |
Oral |
Tablet |
20186 |
5/2008 |
Brimonidine Tartrate |
Draft |
Ophthalmic |
Solution/Drops |
21770
21262
76260 |
9/2008 |
Bumetanide |
Draft |
Oral |
Tablet |
18225 |
7/2008 |
Bupropion HCl
|
Draft |
Oral |
Tablet, Extended Release |
21515 |
4/2008 |
Busulfan |
Draft |
Oral |
Tablet |
09386 |
7/2008 |
C |
Calcitriol |
Draft |
Oral |
Capsule |
18044 |
7/2008 |
Candesartan Cilexetil |
Final |
Oral |
Tablet |
20838 |
5/2008 |
Candesartan Cilexetil; Hydrochlorothiazide
|
Draft |
Oral |
Tablet |
21093 |
9/2008 |
Capecitabine |
Draft |
Oral |
Tablet |
20896 |
7/2008 |
Carbamazepine |
Draft |
Oral |
Tablet, Extended Release |
20234 |
2/2008 |
Carbamazepine |
Draft |
Oral |
Capsule, Extended Release |
20712 |
11/2007 |
Carbamazepine |
Final |
Oral |
Suspension |
18927 |
5/2008 |
Carbidopa; Entacapone; Levodopa
|
Draft |
Oral |
Tablet |
21485 |
9/2008 |
Carvedilol |
Final |
Oral |
Tablet |
20297 |
5/2008 |
Cefdinir |
Draft |
Oral |
Capsule |
50739 |
1/2008 |
Cefditoren Pivoxil |
Final |
Oral |
Tablet |
21222 |
5/2008 |
Cefixime |
Draft |
Oral |
Suspension |
65129
65355 |
1/2008 |
Celecoxib |
Draft |
Oral |
Capsule |
20998 |
5/2007 |
Cetirizine HCl |
Final |
Oral |
Tablet, Chewable |
21621 |
5/2008 |
Cetirizine HCl; Pseudoephedrine HCl |
Draft |
Oral |
Tablet, Extended Release |
21150 |
2/2008 |
Cevimeline HCl |
Final |
Oral |
Capsule |
20989 |
5/2008 |
Cilostazol |
Final |
Oral |
Tablet |
20863 |
5/2008 |
Cinacalcet HCl |
Final |
Oral |
Tablet |
21688 |
5/2008 |
Ciprofloxacin HCl |
Draft |
Oral |
Tablet, Extended Release |
21744 |
11/2007 |
Ciprofloxacin; Ciprofloxacin HCl |
Draft |
Oral |
Tablet, Extended Release |
21473 |
1/2008 |
Citalopram HBr |
Draft |
Oral |
Capsule |
77668 |
9/2008 |
Citalopram HBr |
Draft |
Oral |
Tablet |
20822 |
8/2008 |
Clarithromycin |
Draft |
Oral |
Tablet, Extended Release |
50775 |
1/2008 |
Clarithromycin |
Final |
Oral |
Suspension |
50698 |
5/2008 |
Clonidine HCl |
Final |
Oral |
Tablet |
17407 |
5/2008 |
Clopidogrel Bisulfate
|
Draft |
Oral |
Tablet |
20839 |
8/2008 |
Clotrimazole |
Draft |
Oral |
Troche/Lozenge |
18713 |
9/2008 |
Colesevelam HCl |
Draft |
Oral |
Tablet |
21176 |
7/2008 |
Cyclobenzaprine HCl |
Draft |
Oral |
Capsule, Extended Release |
21777 |
8/2008 |
D |
Danazol |
Final |
Oral |
Capsule |
74582 |
5/2008 |
Dantrolene Sodium |
Draft |
Oral |
Capsule |
76856 |
5/2007 |
Darifenacin HBr |
Final |
Oral |
Tablet, Extended Release |
21513 |
5/2008 |
Darunavir Ethanolate |
Draft |
Oral |
Tablet |
21976 |
11/2007 |
Deferasirox |
Final |
Oral |
Tablet, For Suspension |
21882 |
5/2008 |
Delavirdine Mesylate |
Draft |
Oral |
Tablet |
20705 |
11/2007 |
Demeclocycline HCl |
Draft |
Oral |
Tablet |
50261 |
10/2008 |
Desogestrel; Ethinyl Estradiol |
Draft |
Oral |
Tablet |
20713 |
8/2008 |
Desloratadine |
Final |
Oral |
Tablet, Orally Disintegrating |
21312 |
5/2008 |
Desloratadine |
Final |
Oral |
Tablet |
21165 |
5/2008 |
Dexmethylphenidate |
Draft |
Oral |
Tablet |
21278 |
2/2008 |
Dextromethorphan Polistirex |
Final |
Oral |
Suspension, Extended Release |
18658 |
5/2008 |
Diclofenac Sodium; Misoprostol |
Final |
Oral |
Tablet, Delayed Release |
20607 |
5/2008 |
Dicloxacillin Sodium |
Final |
Oral |
Capsule |
61454 |
5/2008 |
Didanosine |
Final |
Oral |
Tablet, Chewable |
20154 |
5/2008 |
Didanosine |
Final |
Oral |
Capsule, Delayed Release Pellets |
21183 |
5/2008 |
Diflunisal |
Draft |
Oral |
Tablet |
74400 |
7/2008 |
Digoxin |
Final |
Oral |
Tablet |
20405 |
5/2008 |
Diltiazem HCl |
Draft |
Oral |
Capsule, Extended Release |
20062 |
2/2008 |
Diltiazem HCl |
Draft |
Oral |
Capsule, Extended Release |
20092 |
2/2008 |
Diltiazem HCl |
Draft |
Oral |
Capsule, Extended Release |
20401 |
2/2008 |
Diltiazem HCl |
Draft |
Oral |
Tablet, Extended Release |
21392 |
2/2008 |
Dipyridamole |
Final |
Oral |
Tablet |
12836 |
5/2008 |
Disopyramide Phosphate |
Draft |
Oral |
Capsule |
17447 |
8/2008 |
Disopyramide Phosphate |
Draft |
Oral |
Capsule, Extended Release |
18655 |
10/2008 |
|
|
|
|
|
|
Divalproex Sodium |
Final |
Oral |
Capsule, Delayed Release Pellets |
19680 |
5/2008 |
Divalproex Sodium |
Draft |
Oral |
Tablet, Extended Release |
21168 |
2/2008 |
Dofetilide |
Final |
Oral |
Capsule |
20931 |
5/2008 |
Donepezil HCl |
Final |
Oral |
Tablet, Orally Disintegrating |
21720 |
5/2008 |
Donepezil HCl |
Final |
Oral |
Tablet |
20690 |
5/2008 |
Doxazosin Mesylate |
Final |
Oral |
Tablet, Extended Release |
21269 |
5/2008 |
Doxercalciferol |
Draft |
Oral |
Capsule |
20862 |
8/2008 |
Doxycycline |
Draft |
Oral |
Capsule, Delayed Release |
50805 |
2/2008 |
Doxycycline |
Draft |
Oral |
Tablet |
65070 |
1/2008 |
Doxycycline |
Draft |
Oral |
Suspension |
50006 |
8/2008 |
Doxycycline Hyclate |
Draft |
Oral |
Capsule |
50007 |
7/2008 |
Drospirenone; Estradiol |
Final |
Oral |
Tablet |
21355 |
5/2008 |
Duloxetine HCl |
Final |
Oral |
Capsule, Delayed Release Pellets |
21427 |
5/2008 |
Dutasteride |
Final |
Oral |
Capsule |
21319 |
5/2008 |
E |
Efavirenz |
Final |
Oral |
Capsule |
20972 |
5/2008 |
Efavirenz |
Final |
Oral |
Tablet |
21360 |
5/2008 |
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate |
Draft |
Oral |
Tablet |
21937 |
10/2008 |
Emtricitabine |
Final |
Oral |
Capsule |
21500 |
5/2008 |
Enalapril Maleate |
Draft |
Oral |
Tablet |
18998 |
8/2008 |
Entacapone |
Final |
Oral |
Tablet |
20796 |
5/2008 |
Entecavir |
Final |
Oral |
Tablet |
21797 |
5/2008 |
Eplerenone |
Final |
Oral |
Tablet |
21437 |
5/2008 |
Eprosartan Mesylate |
Draft |
Oral |
Tablet |
20738 |
7/2008 |
Eprosartan Mesylate; Hydrochlorothiazide |
Draft |
Oral |
Tablet |
21268 |
2/2008 |
Erlotinib HCl |
Final |
Oral |
Tablet |
21743 |
2/2008 |
Escitalopram Oxalate |
Draft |
Oral |
Capsule |
77660 |
9/2008 |
Escitalopram Oxalate |
Final |
Oral |
Tablet |
21323 |
5/2008 |
Esomeprazole Magnesium |
Final |
Oral |
Capsule, Delayed Release Pellets |
21153 |
5/2008 |
Estrogens, Esterified |
Draft |
Oral |
Tablet |
84948
84949
84950
84951
|
2/2008 |
Eszopiclone |
Draft |
Oral |
Tablet |
21476 |
1/2008 |
Ethambutol HCl |
Draft |
Oral |
Tablet |
75095 |
1/2008 |
Ethinyl Estradiol; Levonorgestrel |
Draft |
Oral |
Tablet |
20860 |
10/2008 |
Ethinyl Estradiol; Levonorgestrel |
Draft |
Oral |
Tablet |
21840 |
2/2008 |
Ethinyl Estradiol; Levonorgestrel |
Draft |
Oral |
Tablet |
21544 |
2/2008 |
Ethinyl Estradiol; Norethindrone Acetate |
Draft |
Oral |
Tablet |
20130 |
7/2008 |
Ethinyl Estradiol; Norethindrone Acetate |
Draft |
Oral |
Tablet |
21065 |
7/2008 |
Ethosuximide |
Draft |
Oral |
Capsule |
12380 |
7/2008 |
Etidronate Disodium |
Final |
Oral |
Tablet |
17831 |
5/2008 |
Exemestane |
Final |
Oral |
Tablet |
20753 |
5/2008 |
Ezetimibe |
Draft |
Oral |
Tablet |
21445 |
10/2008 |
Ezetimibe; Simvastatin |
Draft |
Oral |
Tablet |
21687 |
9/2008 |
F |
Famciclovir |
Draft |
Oral |
Tablet |
20363 |
8/2008 |
Famotidine |
Final |
Oral |
Tablet, Orally Disintegrating |
21712 |
5/2008 |
Famotidine |
Final |
Oral |
Tablet |
19462
20325 |
5/2008 |
Felbamate |
Draft |
Oral |
Tablet |
20189 |
8/2007 |
Felbamate |
Draft |
Oral |
Suspension |
20189 |
8/2007 |
Fenofibrate |
Draft |
Oral |
Tablet |
22118 |
9/2008 |
Fenofibrate |
Draft |
Oral |
Capsule |
21612 |
2/2008 |
Fenofibrate |
Final |
Oral |
Capsule |
21695 |
5/2008 |
Fenofibrate |
Final |
Oral |
Tablet |
21656 |
5/2008 |
Fenofibrate |
Draft |
Oral |
Tablet |
21350 |
10/2008 |
Fexofenadine HCl |
Draft |
Oral |
Tablet, Orally Disintegrating |
21909 |
8/2008 |
Fexofenadine HCl
|
Draft |
Oral |
Capsule |
20625 |
9/2008 |
Fexofenadine HCl
|
Draft |
Oral |
Tablet |
76191 |
9/2008 |
Flavoxate HCl |
Draft |
Oral |
Tablet |
16769 |
5/2007 |
Fluconazole |
Final |
Oral |
Tablet |
19949 |
5/2008 |
Fluvastatin Sodium |
Draft |
Oral |
Capsule |
20261 |
1/2008 |
Fluvastatin Sodium |
Draft |
Oral |
Tablet, Extended Release |
21192 |
1/2008 |
Fluoxetine HCl;
Olanzapine |
Final |
Oral |
Capsule |
21520 |
5/2008 |
Fosamprenavir Calcium |
Draft |
Oral |
Suspension |
22116 |
11/2007 |
Fosamprenavir Calcium |
Final |
Oral |
Tablet |
21548 |
5/2008 |
Fosinopril Sodium |
Final |
Oral |
Tablet |
19915 |
5/2008 |
Fosinopril Sodium; Hydrochlorothiazide
|
Draft |
Oral |
Tablet |
20286 |
9/2008 |
Frovatriptan Succinate |
Draft |
Oral |
Tablet |
21006 |
10/2008 |
G |
Gabapentin |
Draft |
Oral |
Capsule |
20235 |
5/2007 |
Gabapentin |
Final |
Oral |
Tablet |
20882 |
5/2008 |
Galantamine HBr |
Draft |
Oral |
Capsule, Extended Release |
21615 |
5/2007 |
Ganciclovir |
Draft |
Oral |
Capsule |
19661 |
8/2007 |
Gatifloxacin 0.3% |
Draft |
Ophthalmic |
Solution |
21493 |
7/2008 |
Gemifloxacin Mesylate |
Final |
Oral |
Tablet |
21158 |
5/2008 |
Glimepiride |
Final |
Oral |
Tablet |
20496 |
5/2008 |
Glimepiride; Rosiglitazone Maleate |
Draft |
Oral |
Tablet |
21700 |
11/2007 |
Glipizide |
Draft |
Oral |
Tablet, Extended-Release |
20329 |
7/2008 |
Glipizide; Metformin HCl |
Final |
Oral |
Tablet |
21460 |
5/2008 |
Glyburide; Metformin HCl |
Final |
Oral |
Tablet |
21178 |
5/2008 |
Goserelin Acetate |
Draft |
Subcutaneous |
Implant |
20578
19726 |
10/2008 |
Granisetron HCl |
Final |
Oral |
Tablet |
20305 |
5/2008 |
Griseofulvin, Ultramicrocrystalline |
Draft |
Oral |
Tablet |
50475 |
10/2008 |
H |
Hydralazine HCl |
Draft |
Oral |
Tablet |
89098
89097
88467
88468 |
7/2008 |
Hydrochlorothiazide |
Final |
Oral |
Capsule |
20504 |
5/2008 |
Hydrochlorothiazide; Irbesartan |
Final |
Oral |
Tablet |
20758 |
5/2008 |
Hydrochlorothiazide; Lisinopril
|
Final |
Oral |
Tablet |
19888 |
12/2008 |
Hydrochlorothiazide; Losartan Potassium |
Final |
Oral |
Tablet |
20387 |
5/2008 |
Hydrochlorothiazide; Olmesartan Medoxomil |
Final |
Oral |
Tablet |
21532 |
5/2008 |
Hydrochlorothiazide and Telmisartan |
Draft |
Oral |
Tablet |
21162 |
7/2008 |
Hydrochlorothiazide; Triamterene |
Draft |
Oral |
Capsule |
16042
73191 |
10/2008 |
Hydrochlorothiazide; Valsartan
|
Draft |
Oral |
Tablet |
20818 |
7/2008 |
Hydroxyurea |
Draft |
Oral |
Capsule |
16295 |
8/2008 |
I |
Ibandronate Sodium |
Final |
Oral |
Tablet |
21455 |
5/2008 |
Ibuprofen |
Draft |
Oral |
Suspension |
20516
19842 |
10/2008 |
Ibuprofen |
Draft |
Oral |
Suspension, Drops |
20603 |
10/2008 |
Ibuprofen; Pseudoephedrine HCl
|
Draft |
Oral |
Suspension |
21128 |
8/2007 |
Indapamide |
Draft |
Oral |
Tablet |
74461 |
7/2008 |
Indinavir Sulfate |
Final |
Oral |
Capsule |
20685 |
5/2008 |
Irbesartan |
Final |
Oral |
Tablet |
20757 |
5/2008 |
Isoniazid |
Draft |
Oral |
Tablet |
08678 |
7/2008 |
Isosorbide Mononitrate |
Final |
Oral |
Tablet, Extended Release |
20225 |
5/2008 |
Isotretinoin |
Draft |
Oral |
Capsule |
18662 |
9/2008 |
Isradipine |
Final |
Oral |
Capsule |
77317 |
5/2008 |
Isradipine |
Final |
Oral |
Tablet, Extended Release |
20336 |
5/2008 |
Itraconazole |
Draft |
Oral |
Capsule |
20083 |
5/2007 |
K |
Ketoconazole USP, 2% |
Draft |
Topical |
Shampoo (Suspension) |
19927 |
7/2008 |
Ketorolac Tromethamine |
Draft |
Oral |
Tablet |
74761 |
7/2008 |
L |
Lamivudine |
Draft |
Oral |
Tablet |
21003 |
11/2007 |
Lamivudine |
Final |
Oral |
Tablet |
20564 |
5/2008 |
Lamivudine; Zidovudine |
Final |
Oral |
Tablet |
20857 |
5/2008 |
Lamotrigine |
Final |
Oral |
Tablet, Chewable |
20764 |
5/2008 |
Lamotrigine |
Final |
Oral |
Tablet |
20241 |
5/2008 |
Lansoprazole |
Draft |
Oral |
Tablet, Delayed-Release, Orally Disintegrating |
21428 |
10/2008 |
Latanoprost |
Draft |
Ophthalmic |
Solution |
20597 |
9/2008 |
Leflunomide |
Draft |
Oral |
Tablet |
20905 |
8/2007 |
Letrozole |
Draft |
Oral |
Tablet |
20726 |
7/2008 |
Leucovorin Calcium |
Draft |
Oral |
Tablet |
72733
72734
72735
72736 |
7/2008 |
Leuprolide Acetate |
Draft |
Implantation |
Implant |
21088 |
7/2008 |
Levocetirizine Dihydrochloride |
Draft |
Oral |
Tablet |
22064 |
10/2008 |
Levofloxacin |
Draft |
Oral |
Tablet |
20634 |
8/2008 |
Levonorgestrel |
Final |
Oral |
Tablet |
21045 |
5/2008 |
Lidocaine |
Draft |
Topical |
Patch |
20612 |
5/2007 |
Linezolid |
Draft |
Oral |
Tablet |
21130 |
1/2008 |
Liothyronine Sodium |
Final |
Oral |
Tablet |
10379 |
5/2008 |
Lisdexamfetamine Dimesylate |
Draft |
Oral |
Capsule |
21977 |
9/2008 |
Lisinopril |
Draft |
Oral |
Tablet |
19777 |
1/2008 |
Lithium Carbonate |
Draft |
Oral |
Capsule |
17812 |
7/2008 |
Lopinavir; Ritonavir |
Draft |
Oral |
Capsule |
21226 |
8/2008 |
Lopinavir; Ritonavir |
Draft |
Oral |
Tablet |
21906 |
11/2007 |
Loratadine |
Draft |
Oral |
Tablet |
19658 |
7/2008 |
Loratadine |
Final |
Oral |
Tablet, Orally Disintegrating |
20704 |
5/2008 |
Losartan Potassium |
Final |
Oral |
Tablet |
20386 |
5/2008 |
M |
Mebendazole |
Draft |
Oral |
Tablet, Chewable |
73580 |
9/2008 |
Mefloquine HCl |
Final |
Oral |
Tablet |
19591 |
5/2008 |
Meloxicam |
Final |
Oral |
Suspension |
21530 |
5/2008 |
Meloxicam |
Final |
Oral |
Tablet |
20938 |
5/2008 |
Melphalan |
Draft |
Oral |
Tablet |
14691 |
7/2008 |
Memantine HCl |
Draft |
Oral |
Tablet |
21487 |
1/2008 |
Mercaptopurine |
Final |
Oral |
Tablet |
09053 |
5/2008 |
Mesalamine |
Draft |
Rectal |
Enema |
19618 |
1/2008 |
Mesalamine |
Draft |
Rectal |
Suppository |
21252 |
5/2007 |
Metaxalone |
Draft |
Oral |
Tablet |
13217 |
5/2007 |
Metformin HCl |
Draft |
Oral |
Tablet |
20357 |
7/2008 |
Metformin HCl |
Final |
Oral |
Tablet, Extended Release |
21202 |
5/2008 |
Metformin HCl; Pioglitazone |
Final |
Oral |
Tablet |
21842 |
5/2008 |
Methadone HCl |
Draft |
Oral |
Tablet |
06134
17058 |
7/2008 |
Metoprolol Succinate
|
Draft |
Oral |
Tablet, Extended Release |
19962 |
4/2008 |
Midodrine HCl |
Draft |
Oral |
Tablet |
19815 |
8/2008 |
Miglustat |
Final |
Oral |
Capsule |
21348 |
5/2008 |
Minocycline HCl |
Draft |
Oral |
Capsule |
63009
63011 |
7/2008 |
Minocycline HCl |
Draft |
Oral |
Tablet, Extended Release |
50808 |
11/2007 |
Minoxidil
|
Draft |
Oral |
Tablet |
18154 |
7/2008 |
Mirtazapine |
Final |
Oral |
Tablet, Orally Disintegrating |
21208 |
5/2008 |
Modafinil |
Final |
Oral |
Tablet |
20717 |
5/2008 |
Moexipril HCl |
Final |
Oral |
Tablet |
20312 |
5/2008 |
Montelukast |
Draft |
Oral |
Granule |
21409 |
7/2008 |
Montelukast Sodium |
Draft |
Oral |
Tablet |
20829 |
7/2008 |
Montelukast Sodium
|
Draft |
Oral |
Tablet, Chewable |
20830 |
7/2008 |
Morphine Sulfate
|
Draft |
Oral |
Capsule, Extended Release |
20616 |
9/2008 |
Moxifloxacin HCl |
Draft |
Oral |
Tablet |
21085 |
7/2008 |
Mycophenolate Mofetil |
Draft |
Oral |
Capsule |
50722 |
8/2007 |
Mycophenolate Mofetil HCl |
Draft |
Oral |
Tablet |
50723 |
8/2007 |
N |
Nabilone |
Draft |
Oral |
Capsule |
18677 |
7/2008 |
Nabumetone |
Final |
Oral |
Tablet |
75189 |
5/2008 |
Naproxen Sodium |
Draft |
Oral |
Tablet |
17581 |
7/2008 |
Naproxen Sodium |
Draft |
Oral |
Tablet |
18164 |
7/2008 |
Naproxen Sodium |
Draft |
Oral |
Tablet |
20204 |
7/2008 |
Naratriptan HCl |
Draft |
Oral |
Tablet |
20763 |
7/2008 |
Nateglinide |
Final |
Oral |
Tablet |
21204 |
5/2008 |
Nelfinavir Mesylate |
Draft |
Oral |
Suspension |
20778 |
11/2007 |
Nelfinavir Mesylate |
Final |
Oral |
Tablet |
20779
21503
|
5/2008 |
Nevirapine |
Final |
Oral |
Suspension |
20933 |
5/2008 |
Nevirapine |
Draft |
Oral |
Tablet |
20636 |
11/2007 |
Nicardipine HCl |
Draft |
Oral |
Capsule, Extended Release |
20005 |
7/2008 |
O |
Olanzapine |
Draft |
Oral |
Tablet |
20592 |
8/2008 |
Olanzapine |
Final |
Oral |
Tablet, Orally Disintegrating |
21086 |
5/2008 |
Olmesartan Medoxomil |
Final |
Oral |
Tablet |
21286 |
5/2008 |
Olopatadine HCl |
Draft |
Ophthalmic |
Solution |
21545
20688 |
9/2008 |
Olsalazine Sodium |
Final |
Oral |
Capsule |
19715 |
5/2008 |
Omeprazole |
Final |
Oral |
Capsule, Delayed Release |
19810 |
5/2008 |
Omeprazole Magnesium |
Final |
Oral |
Tablet, Delayed Release |
21229 |
5/2008 |
Omeprazole; Sodium Bicarbonate |
Draft |
Oral |
Capsule |
21849 |
7/2008 |
Omeprazole; Sodium Bicarbonate |
Final |
Oral |
Suspension |
21636 |
5/2008 |
Omeprazole, Sodium Bicarbonate; Magnesium Hydroxide |
Draft |
Oral |
Tablet, Chewable |
21850 |
2/2008 |
Ondansetron |
Final |
Oral |
Tablet, Orally Disintegrating |
20781 |
5/2008 |
Ondansetron HCl |
Final |
Oral |
Tablet |
20103 |
5/2008 |
Oxcarbazepine |
Final |
Oral |
Suspension |
21285 |
5/2008 |
Oxcarbazepine |
Final |
Oral |
Tablet |
21014 |
5/2008 |
Oxymorphone HCl |
Draft |
Oral |
Tablet |
21611 |
1/2008 |
Oxymorphone HCl |
Draft |
Oral |
Tablet, Extended Release |
21610 |
11/2007 |
P |
Paliperidone |
Draft |
Oral |
Tablet, Extended Release |
21999 |
11/2007 |
Pantoprazole Sodium |
Final |
Oral |
Tablet, Delayed Release |
20987 |
5/2008 |
Paricalcitol |
Draft |
Oral |
Capsule |
21606 |
11/2007 |
Paroxetine HCl |
Draft |
Oral |
Tablet |
20031 |
8/2008 |
Penicillamine |
Draft |
Oral |
Capsule |
19853 |
8/2008 |
Perindopril Erbumine |
Final |
Oral |
Tablet |
20184 |
5/2008 |
Phenoxybenzamine |
Draft |
Oral |
Capsule |
08708 |
7/2008 |
Phenytoin Sodium |
Final |
Oral |
Capsule, Extended |
84349 |
5/2008 |
Phenytoin Sodium |
Final |
Oral |
Capsule, Extended |
40298 |
5/2008 |
Phenytoin |
Draft |
Oral |
Tablet, Chewable |
84427 |
1/2008 |
Phenytoin |
Final |
Oral |
Suspension |
08762 |
5/2008 |
Pilocarpine HCl |
Final |
Oral |
Tablet |
20237 |
5/2008 |
Pimozide |
Draft |
Oral |
Tablet |
17473 |
2/2008 |
Posaconazole |
Draft |
Oral |
Suspension |
22003 |
11/2007 |
Pravastatin Sodium |
Final |
Oral |
Tablet |
19898 |
5/2008 |
Prednisolone Sodium Phosphate |
Draft |
Oral |
Tablet, Orally Disintegrating |
21959 |
8/2008 |
Q |
Quetiapine Fumarate |
Draft |
Oral |
Tablet, Extended Release |
22047 |
7/2008 |
Quetiapine Fumarate |
Final |
Oral |
Tablet |
20639 |
5/2008 |
Quinapril HCl |
Final |
Oral |
Tablet |
19885 |
5/2008 |
Quinine Sulfate |
Draft |
Oral |
Capsule |
21799 |
1/2008 |
R |
Raloxifene HCl |
Final |
Oral |
Tablet |
20815 |
5/2008 |
Ramipril |
Draft |
Oral |
Tablet |
22021 |
8/2008 |
Ramipril |
Final |
Oral |
Capsule |
19901 |
5/2008 |
Repaglinide |
Draft |
Oral |
Tablet |
20741 |
8/2008 |
Ribavirin |
Final |
Oral |
Capsule |
20903 |
5/2008 |
Ribavirin |
Final |
Oral |
Tablet |
77456 |
5/2008 |
Rifampin |
Final |
Oral |
Capsule |
50420
62303 |
5/2008 |
Riluzole |
Final |
Oral |
Tablet |
20599 |
5/2008 |
Risedronate Sodium; Calcium Carbonate |
Final |
Oral |
Tablet |
21823 |
5/2008 |
Risedronate Sodium
|
Draft |
Oral |
Tablet |
20835 |
12/2008 |
Risperidone |
Draft |
Oral |
Tablet |
20272 |
5/2007 |
Ritonavir |
Final |
Oral |
Capsule |
20945 |
5/2008 |
Rizatriptan Benzoate |
Final |
Oral |
Tablet |
20864 |
5/2008 |
Rosiglitazone Maleate |
Final |
Oral |
Tablet |
21071 |
5/2008 |
Rosuvastatin Calcium |
Final |
Oral |
Tablet |
21366 |
5/2008 |
S |
Sapropterin Dihydrochloride |
Draft |
Oral |
Tablet |
22181 |
9/2008 |
Saquinavir Mesylate |
Draft |
Oral |
Capsule |
20628 |
11/2007 |
Saquinavir Mesylate |
Draft |
Oral |
Tablet |
21785 |
11/2007 |
Selegiline HCl |
Draft |
Oral |
Tablet, Orally Disintegrating |
21479 |
9/2008 |
Sevelamer Carbonate |
Draft |
Oral |
Tablet |
22127 |
9/2008 |
Sevelamer HCl |
Draft |
Oral |
Tablet |
21179 |
7/2008 |
Sertraline HCl |
Final |
Oral |
Tablet |
19839 |
5/2008 |
Sibutramine HCl |
Final |
Oral |
Capsule |
20632 |
5/2008 |
Sildenafil Citrate |
Final |
Oral |
Tablet |
20895
21845 |
12/2008 |
Simvastatin |
Final |
Oral |
Tablet |
19766 |
5/2008 |
Simvastatin |
Draft |
Oral |
Tablet, Orally Disintegrating |
21961 |
8/2008 |
Sirolimus
|
Draft |
Oral |
Tablet |
21110 |
9/2008 |
Sitagliptin Phosphate; Metformin HCl |
Draft |
Oral |
Tablet |
22044 |
9/2008 |
Sodium Iodide, I-123 |
Draft |
Oral |
Capsule |
18671 |
7/2008 |
Solifenacin Succinate |
Draft |
Oral |
Tablet |
21518 |
2/2008 |
Stavudine |
Final |
Oral |
Capsule |
20412 |
5/2008 |
Stavudine |
Draft |
Oral |
Capsule |
20412 |
8/2008 |
Sulfadiazine |
Draft |
Oral |
Tablet |
40091 |
7/2008 |
Sulfamethoxazole; Trimethoprim |
Final |
Oral |
Suspension |
77612 |
5/2008 |
Sulfamethoxazole; Trimethoprim |
Draft |
Oral |
Tablet |
17377 |
8/2008 |
Sumatriptan Succinate |
Final |
Oral |
Tablet |
20132 |
5/2008 |
T |
Tacrolimus |
Draft |
Oral |
Capsule |
50708 |
5/2007 |
Tadalafil |
Draft |
Oral |
Tablet |
21368 |
5/2007 |
Tamsulosin HCl |
Final |
Oral |
Capsule |
20579 |
5/2008 |
Telithromycin |
Final |
Oral |
Tablet |
21144 |
5/2008 |
Telmisartan |
Final |
Oral |
Tablet |
20850 |
5/2008 |
Tenofovir Disoproxil Fumarate |
Draft |
Oral |
Tablet |
21356 |
11/2007 |
Terazosin HCl |
Final |
Oral |
Capsule |
20347 |
5/2008 |
Terbinafine HCl |
Final |
Oral |
Tablet |
20539 |
5/2008 |
Testosterone |
Final |
Oral |
Tablet, Extended Release, Buccal |
21543 |
5/2008 |
Theophylline |
Draft |
Oral |
Capsule, Extended Release |
40052 |
9/2008 |
Tiagabine HCl |
Draft |
Oral |
Tablet |
20646 |
7/2008 |
Ticlopidine HCl |
Final |
Oral |
Tablet |
19979 |
5/2008 |
Tinidazole |
Draft |
Oral |
Tablet |
21618 |
11/2007 |
Tipranavir |
Draft |
Oral |
Capsule |
21814 |
11/2007 |
Tizanidine HCl |
Final |
Oral |
Capsule |
21447 |
5/2008 |
Tolterodine Tartrate |
Final |
Oral |
Tablet |
20771 |
5/2008 |
Topiramate
|
Draft |
Oral |
Tablet |
20505 |
5/2007 |
Topiramate |
Draft |
Oral |
Capsule, Sprinkle |
20844 |
5/2007 |
Torsemide |
Final |
Oral |
Tablet |
20136 |
5/2008 |
Tolterodine Tartrate |
Draft |
Oral |
Tablet, Extended Release |
21228 |
1/2008 |
Tramadol HCl; Acetaminophen |
Final |
Oral |
Tablet |
21123 |
5/2008 |
Tramadol HCl |
Final |
Oral |
Tablet |
20281 |
5/2008 |
Tramadol HCl |
Draft |
Oral |
Tablet, Extended Release |
21692 |
11/2007 |
Trandolapril |
Final |
Oral |
Tablet |
20528 |
5/2008 |
Triamterene |
Final |
Oral |
Capsule |
13174 |
5/2008 |
Triptorelin Pamoate |
Draft |
Intramuscular |
Injectable |
20715
21288 |
7/2008 |
Trospium Chloride |
Draft |
Oral |
Capsule, Extended Release |
22103 |
8/2008 |
Trospium Chloride |
Draft |
Oral |
Tablet |
21595 |
11/2007 |
U |
Ursodiol |
Draft |
Oral |
Tablet |
20675 |
7/2008 |
V |
Valacyclovir HCl |
Final |
Oral |
Tablet |
20487 |
5/2008 |
Valganciclovir HCl |
Draft |
Oral |
Tablet |
21304 |
8/2008 |
Valsartan |
Final |
Oral |
Tablet |
21283 |
5/2008 |
Vardenafil HCl |
Final |
Oral |
Tablet |
21400 |
5/2008 |
Varenicline Tartrate |
Draft |
Oral |
Tablet |
21928 |
11/2007 |
Venlafaxine HCl
|
Draft |
Oral |
Capsule, Extended Release |
20699 |
12/2007 |
Verapamil HCl |
Final |
Oral |
Capsule, Extended Release |
19614 |
5/2008 |
Verapamil HCl |
Final |
Oral |
Capsule, Extended Release |
20943 |
5/2008 |
Verapamil HCl |
Draft |
Oral |
Tablet |
18817 |
10/2008 |
Voriconazole |
Final |
Oral |
Suspension |
21630 |
5/2008 |
Vorinostat |
Draft |
Oral |
Capsule |
21991 |
8/2008 |
Z |
Zafirlukast |
Draft |
Oral |
Tablet |
20547 |
2/2008 |
Zaleplon |
Final |
Oral |
Capsule |
20859 |
5/2008 |
Zalcitabine |
Draft |
Oral |
Tablet |
20199 |
2/2008 |
Zidovudine |
Final |
Oral |
Capsule |
19655 |
5/2008 |
Zidovudine |
Final |
Oral |
Tablet |
20518 |
5/2008 |
Zileuton |
Draft |
Oral |
Tablet, Extended Release |
22052 |
7/2008 |
Zileuton |
Draft |
Oral |
Tablet |
20471 |
1/2008 |
Ziprasidone HCl |
Draft |
Oral |
Suspension |
21483 |
7/2008 |
Ziprasidone HCl |
Final |
Oral |
Capsule |
20825 |
5/2008 |
Zolmitriptan
|
Draft |
Oral |
Tablet, Orally Disintegrating |
21231 |
9/2008 |
Zolpidem Tartrate |
Draft |
Oral |
Tablet |
19908 |
5/2007 |
Zonisamide |
Draft |
Oral |
Capsule |
20789 |
1/2008 |