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| Document #
|
| Received Date
|
| Filed Date
|
| Submitter Code
|
| Submitter
|
| FR Date
|
| FR Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
|
Files before 1/05/1981, and those cited below which are not currently linked, may be viewed at Dockets Management Public Reading Room.
|
|
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|
| ANS1
|
| 01/07/1981
|
| 01/07/1981
|
| Federal
Government
|
| HFD-560 to National
Pharmaceutical Mfg. Co.
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| Gerald M. Rachanow
|
|
|
|
|
|
|
|
| ANS2
|
| 01/28/1981
|
| 01/28/1981
|
| Federal
Government
|
| HFD-30
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| Marilyn L. Watson
|
|
|
|
|
|
|
|
| ACK1
|
| 04/07/1981
|
| 04/07/1981
|
| Federal
Government
|
| HFA-305
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| Doris G. Brook
|
|
|
|
|
|
|
|
| EXP1
|
| 01/08/1981
|
| 01/08/1981
|
| Association
|
| NAT ASSN PH MFG
|
|
|
|
|
|
|
| pdf
|
| ANS 81/01/26
|
|
|
| Signature:
|
| NAT ASSN PH MFG
|
|
|
|
|
| LET66
|
| 01/07/1981
|
| 11/25/1980
|
| Private
Industry
|
| NAT PHARM MFG
CO
|
|
|
|
|
|
|
| pdf
|
| ANS 81/01/07
|
|
|
|
|
| Signature:
|
| NAT PHARM MFG CO
|
|
|
| MT9
|
| 01/07/1981
|
| 01/07/1981
|
| Other
Organization
|
| HFD-510 (RACHANOW,
G)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| HFD-510 (RACHANOW, G)
|
|
|
|
|
| CP1
|
| 04/02/1981
|
| 04/07/1981
|
| Private
Industry
|
| Schering
Corp, Dow Chemical, Burroughs Wellcome
|
|
|
|
|
|
|
| Table of Contents
|
| Formerly
Docket No. 76N- 0052/CP 1
|
|
|
|
|
|
|
| Signature:
|
| Roberta L Selman Esq, Kathryn V
Cre
|
|
|
|
|
|
| LET72
|
| 07/20/1981
|
| 07/20/1981
|
| Other
Organization
|
| HFD-510 (GILBERTSON,
W)
|
|
|
|
|
|
|
| pdf
|
| SEE SUP004
|
|
|
| Signature:
|
| HFD-510 (GILBERTSON, W)
|
|
|
|
|
| N1
|
|
|
| 04/30/1981
|
| FDA
|
| FDA
|
|
|
|
|
|
|
| pdf
|
| N 1
46FR25144 5/5/81 EFF 81/05/01
|
|
|
| Signature:
|
| FDA
|
|
|
|
|
|
|
|
|
| LET78
|
| 02/01/1982
|
| 02/01/1982
|
| Other
Organization
|
| HFD-510 (GILBERTSON)
SCHERING CORP
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| HFD-510 (GILBERTSON)
SCHERING
|
|
|
|
|
| LET79
|
| 02/01/1982
|
| 02/01/1982
|
| Other
Organization
|
| HFD-510 (GILBERTSON)
DOW CHEMICAL CO
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| HFD-510 (GILBERTSON) DOW
CHEM
|
|
|
|
|
| LET77
|
| 02/01/1982
|
| 02/01/1982
|
| Other
Organization
|
| HFD-510
(GILBERTSON) BURROUGHS- WELLCO
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| HFD-510 (GILBERTSON)
BURROUG
|
|
|
| LET80
|
| 04/15/1982
|
| 04/15/1982
|
| Other
Organization
|
| HFD-510(GILBERTSON)
VICK
|
|
|
|
|
|
|
| pdf
|
| C111/CR3/SUP15
|
|
|
|
|
| Signature:
|
| HFD-510(GILBERTSON) VICK
|
|
|
| LET81
|
| 06/09/1982
|
| 06/09/1982
|
| Other
Organization
|
| HFD-510(GILBERTSON)
STERLING DRUG INC
|
|
|
|
|
|
|
| pdf
|
| SEE C00125
|
|
|
|
|
| Signature:
|
| HFD-510(GILBERTSON) STERLING
|
|
|
|
|
| C189
|
| 01/20/1983
|
| 01/20/1983
|
| Private
Industry
|
| DORSEY LABS
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| DORSEY LABS
|
|
|
|
|
| CP2
|
| 01/31/1983
|
| 02/01/1983
|
| Association
|
| PA
|
|
|
|
|
|
|
| pdf
|
| ACK 83/02/01
|
|
|
| Signature:
|
| PA
|
|
|
|
|
| ACK6
|
| 02/01/1983
|
| 02/01/1983
|
| Federal
Government
|
| HFA-305 to The
Proprietary Association
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| Doris G. Brook
|
|
|
|
|
|
|
|
| CP3
|
| 02/22/1983
|
| 02/22/1983
|
| Private
Industry
|
| NIXON HARGRAVE DEVANS
& DOYLE (ATTNS)
|
|
|
|
|
|
|
| pdf
|
| ACK 83/02/22
|
|
|
| Signature:
|
| NIXON HARGRAVE DEVANS &
DOYL
|
|
|
|
|
| ACK7
|
| 02/22/1983
|
| 02/22/1983
|
| Federal
Government
|
| HFA-305 to Nixon,
Hargrave, Devans & Doyle
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| Doris G. Brook
|
|
|
| |
|
|
|
|
|
| PAV1
|
| 04/18/1983
|
| 04/18/1983
|
| Other
Organization
|
| HFC-2(RANDOLPH)
|
|
|
|
|
|
|
| pdf
|
| SEE CP0003
|
|
|
| Signature:
|
| HFC-2(RANDOLPH)
|
|
|
|
|
| LET82
|
| 04/20/1983
|
| 04/20/1983
|
| Other
Organization
|
| HFN-510(GILBERTSON)
|
|
|
|
|
|
|
| pdf
|
| SEE CP0002
|
|
|
| Signature:
|
| HFN-510(GILBERTSON)
|
|
|
|
|
| CP4
|
| 09/29/1983
|
| 09/29/1983
|
| Private
Industry
|
| Thompson Medical Co
Inc
|
|
|
|
|
|
|
| pdf
|
| ACK 83/09/29
|
|
|
| Signature:
|
| Stephen Kurzman PC
|
|
|
|
|
| ACK8
|
| 09/29/1983
|
| 09/29/1983
|
| Federal
Government
|
| HFA-305 to Nion,
Hargave, Devane & Doyle
|
|
|
|
|
|
|
| 1
|
|
|
|
|
|
| Signature:
|
| Doris G. Brook
|
|
|
|
|
|
|
|
| CP5
|
| 10/13/1983
|
| 10/13/1983
|
| Private
Industry
|
| THOMPSON MED CO
INC
|
|
|
|
|
|
|
| Table of Contents
|
| ACK 83/10/13
|
|
|
|
|
| Signature:
|
| THOMPSON MED CO INC
|
|
|
| CR1
|
| 11/07/1983
|
| 11/03/1983
|
| Private
Industry
|
| THOMPSON MED CO
INC
|
|
|
|
|
|
|
| pdf
|
| SEE CP0005
|
|
|
|
|
| Signature:
|
| THOMPSON MED CO INC
|
|
|
|
|
| LET83
|
| 12/02/1983
|
| 12/02/1983
|
| Private
Industry
|
| FLEMING &
CO
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| FLEMING & CO
|
|
|
|
|
| MM1
|
| 01/10/1984
|
| 01/10/1984
|
| Other
Organization
|
| HFN-514 (SHORT) &
THOMPSON MED CO REP
|
|
|
|
|
|
|
| html
|
| VOL (1 OF 1)
|
|
|
| Signature:
|
| HFN-514 (SHORT) & THOMPSON
ME
|
|
|
|
|
| MM2
|
| 01/10/1984
|
| 01/10/1984
|
| Other
Organization
|
| HFN-514 (SHORT) &
THOMPSON MED CO REP
|
|
|
|
|
|
|
| pdf
|
| VOL (2 OF 2)
|
|
|
| Signature:
|
| HFN-514 (SHORT) & THOMPSON
ME
|
|
|
|
|
| SUP1
|
| 01/26/1984
|
| 01/26/1984
|
| Private
Industry
|
| Thompson Medical Co
Inc
|
|
|
|
|
|
|
| pdf
|
| SEE CP0005
|
|
|
| Signature:
|
| Edward L Steinberg MSc OD
|
|
|
|
|
| CP6
|
| 02/16/1984
|
| 02/16/1984
|
| Private
Industry
|
| THOMPSON MEDICAL CO
INC
|
|
|
|
|
|
|
| Table of Contents
|
| ACK 84/02/16
|
|
|
| Signature:
|
| THOMPSON MEDICAL CO INC
|
|
|
|
|
| LET84
|
| 02/28/1984
|
| 02/28/1984
|
| Private
Industry
|
| NIXON
HARGRAVE DEVANS&DOYLE/KURZMAN
|
|
|
|
|
|
|
| pdf
|
| CF
|
|
|
|
|
|
|
|
|
| Signature:
|
| NIXON HARGRAVE
DEVANS&DOYLE
|
|
|
| LET85
|
| 04/04/1984
|
| 04/04/1984
|
| Other
Organization
|
| HFN-510(GILBERTSON)
|
|
|
|
|
|
|
| pdf
|
| SEE CP0006
|
|
|
|
|
| Signature:
|
| HFN-510(GILBERTSON)
|
|
|
| MM3
|
| 04/18/1984
|
| 04/18/1984
|
| Other
Organization
|
| HFN-214(SHORT)
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| HFN-214(SHORT)
|
|
|
|
|
| LET86
|
| 05/14/1984
|
| 05/14/1984
|
| Private
Industry
|
| CIBA-GEIGY
|
|
|
|
|
|
|
| pdf, con't
|
|
|
|
|
| Signature:
|
| CIBA-GEIGY
|
|
|
|
|
| PR1
|
| 05/14/1984
|
| 05/14/1984
|
| Private
Industry
|
| CIBA CONSUMER
PHARMACEUTICALS
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| CIBA CONSUMER
PHARMACEUTICA
|
|
|
|
|
| RPT1
|
| 05/18/1984
|
| 05/12/1984
|
| Private
Industry
|
| Thompson Medical Co
Inc
|
|
|
|
|
|
|
| pdf, con't
|
|
|
|
|
| Signature:
|
| Edward L Steinberg MSc OD
|
|
|
|
|
| PR4
|
| 05/18/1984
|
| 05/12/1984
|
| Private
Industry
|
| THOMPSON MEDICAL CO
INC
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| THOMPSON MEDICAL CO INC
|
|
|
|
|
| LET87
|
| 05/25/1984
|
| 05/25/1984
|
| Other
Organization
|
| HFN-210(GILBERTSON TO
CIBA)
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| HFN-210(GILBERTSON TO
CIBA)
| |
|
|
|
|
|
| LET88
|
| 05/25/1984
|
| 05/25/1984
|
| Other
Organization
|
| HFN-210(GILBERTSON TO
THOMPSON)
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| HFN-210(GILBERTSON TO
THOMPS
|
|
|
|
|
| PR3
|
| 05/21/1984
|
| 05/17/1984
|
| Private
Industry
|
| MENLEY & JAMES
LABS
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| MENLEY & JAMES LABS
|
|
|
|
|
| LET89
|
| 06/07/1984
|
| 06/07/1984
|
| Other
Organization
|
| HFN-210(GILBERTSON TO
MENLEY&JAMES)
|
|
|
|
|
|
|
| pdf
|
| SEE PR0003
|
|
|
| Signature:
|
| HFN-210(GILBERTSON TO
MENLEY
|
|
|
|
|
| CP7
|
| 08/13/1984
|
| 08/13/1984
|
| Private
Industry
|
| THOMPSON MEDICAL CO
INC
|
|
|
|
|
|
|
| html
|
| ACK 84/08/13 CF
|
|
|
| Signature:
|
| THOMPSON MEDICAL CO INC
|
|
|
|
|
| LET90
|
| 09/10/1984
|
| 09/10/1984
|
| Other
Organization
|
| HFN-210(GILBERTSON TO THOMPSON MED CO
|
|
|
|
|
|
|
| pdf
|
| SEE CP0007 CF
|
|
|
|
|
|
|
|
|
| Signature:
|
| HFN-210(GILBERTSON TO
THOMPS
|
|
|
| PAV2
|
| 09/17/1984
|
| 09/17/1984
|
| Other
Organization
|
| HFN-210 (GILBERTSON)
TO THOMPSON MED
|
|
|
|
|
|
|
| pdf
|
| SEE CP0004 CF
|
|
|
|
|
| Signature:
|
| HFN-210 (GILBERTSON) TO
THOMP
|
|
|
|
|
| PAV3
|
| 09/17/1984
|
| 09/17/1984
|
| Other
Organization
|
| HFN-210 (GILBERTSON)
TO THOMPSON MED
|
|
|
|
|
|
|
| pdf
|
| SEE CP0005 CF
|
|
|
| Signature:
|
| HFN-210 (GILBERTSON) TO
THOMP
|
|
|
|
|
| CP8
|
| 09/20/1984
|
| 09/20/1984
|
| Private
Industry
|
| THOMPSON MEDICAL CO
INC
|
|
|
|
|
|
|
| 9
|
| ACK 84/09/20
|
|
|
| Signature:
|
| THOMPSON MEDICAL CO INC
|
|
|
|
|
| LET91
|
| 10/15/1984
|
| 10/15/1984
|
| Other
Organization
|
| HFN-210 (GILBERTSON)
THOMPSON MED CO
|
|
|
|
|
|
|
| pdf
|
| CLOSED 84/10/12
|
|
|
| Signature:
|
| HFN-210 (GILBERTSON)
THOMPSO
|
|
|
|
|
| EA1
|
| 01/15/1985
|
| 01/15/1985
|
| Federal
Government
|
| HFN-210
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
| Signature:
|
| William E. Gilbertson
|
|
|
|
|
|
|
|
| NPR1
|
|
|
| 01/14/1985
|
| FDA
|
| FDA
|
|
|
|
|
| 05/15/1985
|
| pdf, con't
|
| NTF
|
|
|
| Signature:
|
| FDA
|
|
|
|
|
| MM4
|
| 03/05/1985
|
| 03/05/1985
|
| Other
Organization
|
| HFN-213 (MUSTAFA)
& MCNEIL PROD ET AL
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
|
|
| Signature:
|
| HFN-213 (MUSTAFA) & MCNEIL
PRO
|
|
|
| C190
|
| 03/13/1985
|
| 03/09/1985
|
| Individual
Consumer
|
| BISHOP, W MR
|
|
|
|
|
|
|
|
|
| CF
|
|
|
|
|
| C191
|
| 03/13/1985
|
| 03/04/1985
|
| Individual
Consumer
|
| ADAMS, M MS
|
|
|
|
|
|
|
|
|
| CF
|
|
|
|
|
| C192
|
| 03/19/1985
|
| 03/19/1985
|
| Individual
Consumer
|
| BLACKMAN, M &
S
|
|
|
|
|
|
|
|
|
| CF
|
|
|
|
|
| C193
|
| 03/20/1985
|
| 03/18/1985
|
| Individual
Consumer
|
| RAKES, R MRS
|
|
|
|
|
|
|
|
|
| CF
|
|
|
|
|
| C194
|
| 03/21/1985
|
| 03/21/1985
|
| Individual
Consumer
|
| COX, M PHG
|
|
|
|
|
|
|
|
|
| TFM
|
|
|
|
|
| C195
|
| 03/22/1985
|
| 03/22/1985
|
| Individual
Consumer
|
| BRAIDIC, J
|
|
|
|
|
|
|
|
|
| TFM CF
|
|
|
|
|
| C196
|
| 03/26/1985
|
| 03/23/1985
|
| Individual
Consumer
|
| ACCORD, M MS
|
|
|
|
|
|
|
|
|
| TFM CF
|
|
|
|
|
|
|
| APE1
|
| 04/03/1985
|
| 04/03/1985
|
| Private
Industry
|
| VICKS RES CTR
RICHARDSON-VICKS INC
|
|
|
|
|
|
|
|
|
| TFM
|
|
|
|
|
| C197
|
| 04/16/1985
|
| 04/16/1985
|
| Individual
Consumer
|
| BROWN, J MR
|
|
|
|
|
|
|
|
|
| TFM CF
|
|
|
|
|
| C198
|
| 03/15/1985
|
| 05/01/1985
|
| Individual
Consumer
|
| SNORES, L MS
|
|
|
|
|
|
|
|
|
| TFM
|
|
|
|
|
| C199
|
| 05/02/1985
|
| 04/30/1985
|
| Individual
Consumer
|
| TERRY, F MS
|
|
|
|
|
|
|
|
|
| TFM CF
|
|
|
|
|
| C200
|
| 05/06/1985
|
| 05/03/1985
|
| Private
Industry
|
| BRISTOL-MYERS
PRODS
|
|
|
|
|
|
|
| pdf
|
| TFM
|
|
|
| Signature:
|
| BRISTOL-MYERS PRODS
|
|
|
|
|
| APE2
|
| 05/14/1985
|
| 05/14/1985
|
| Private
Industry
|
| VICKS RES CTR
RICHARSON-VICKS INC
|
|
|
|
|
|
|
|
|
| TFM
|
|
|
|
|
| C201
|
| 05/13/1985
|
| 05/09/1985
|
| Private
Industry
|
| BOEHRINGER INGELHEIM
PHARMS INC
|
|
|
|
|
|
|
| pdf
|
| TFM
|
|
|
| Signature:
|
| BOEHRINGER INGELHEIM
PHARMS
|
|
|
|
|
| C202
|
| 05/14/1985
|
| 05/13/1985
|
| Private
Industry
|
| MILES LABS INC
|
|
|
|
|
|
|
| pdf
|
| TFM
|
|
|
| Signature:
|
| MILES LABS INC
|
|
|
|
|
| C203
|
| 05/15/1985
|
| 05/15/1985
|
| Individual
Consumer
|
| FINKELSTEIN, V
MS
|
|
|
|
|
|
|
|
|
| TFM
|
|
|
|
|
| C204
|
| 05/15/1985
|
| 05/15/1985
|
| Private
Industry
|
| MENLEY & JAMES
LABS A SMITHKLINE BECK
|
|
|
|
|
|
|
| pdf
|
| TFM
|
|
|
| Signature:
|
| MENLEY & JAMES LABS A
SMITHKL
|
|
|
|
|
| C205
|
| 05/15/1985
|
| 05/15/1985
|
| Private
Industry
|
| BURROUGHS WELLCOME
CO
|
|
|
|
|
|
|
| pdf
|
| TFM
|
|
|
| Signature:
|
| BURROUGHS WELLCOME CO
|
|
|
|
|
| C206
|
| 05/16/1985
|
| 05/15/1985
|
| Association
|
| PROPRIETARY
ASSN
|
|
|
|
|
|
|
| pdf, Appendix
|
| TFM
|
|
|
| Signature:
|
| PROPRIETARY ASSN
|
|
|
|
|
| C207
|
| 05/16/1985
|
| 05/15/1985
|
| Private
Industry
|
| MCNEIL CONSUMER PRODS
CO
|
|
|
|
|
|
|
| pdf
|
| TFM
|
|
|
|
|
| Signature:
|
| MCNEIL CONSUMER PRODS CO
|
|
|
| C208
|
| 05/17/1985
|
| 05/15/1985
|
| Private
Industry
|
| SCHERING-PLOUGH
CORP
|
|
|
|
|
|
|
| pdf
|
| TFM
|
|
|
| Signature:
|
| SCHERING-PLOUGH CORP
|
|
|
|
|
| C209
|
| 05/20/1985
|
| 05/15/1985
|
| Private
Industry
|
| PLOUGH INC
|
|
|
|
|
|
|
| pdf
|
|
|
|
|
| Signature:
|
| PLOUGH INC
|
|
|
|
|
| C210
|
| 05/29/1985
|
| 05/23/1985
|
| Private
Industry
|
| MCNETT, M MD
|
|
|
|
|
|
|
|
|
| TFM
|
|
|
|
|
| CP9
|
| 06/21/1985
|
| 06/21/1985
|
| Private
Industry
|
| THOMPSON MED CO INC
VOL 1 OF 1)
|
|
|
|
|
|
|
| htm
|
| TFM ACK 85/6/21
|
|
|
| Signature:
|
| THOMPSON MED CO INC VOL 1
|
|
|
|
|
| LET92
|
| 07/15/1985
|
| 07/15/1985
|
| Other
Organization
|
| HFN-210 (GILBERTSON)
TO KURZMAN, S PC
|
|
|
|
|
|
|
| pdf
|
| INT. 85/07/12
|
|
|
| Signature:
|
| HFN-210 (GILBERTSON) TO
KURZM
|
|
|
|
|
| C211
|
| 07/17/1985
|
| 06/11/1985
|
| Individual
Consumer
|
| LANIGAN, C MS
|
|
|
|
|
|
|
|
|
| ANS 85/07/17
|
|
