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1976N-0052N: OTC Nasal Decongestants
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| Document #
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| Received Date
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| Filed Date
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| Submitter Code
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| Submitter
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| FR Date
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| FR Page
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| Comment Date
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| Files
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| Remarks
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| MM5
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| 07/18/1985
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| 07/18/1985
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| Other
Organization
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| HFN-213 (COTHRAN)
& RICHARDSON-VICKS
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| C212
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| 08/13/1985
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| 08/13/1985
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| Private
Industry
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| VICKS RES CTR
RICHARDSON-VICKS INC
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| VOL 1 OF 1
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| Signature:
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| VICKS RES CTR
RICHARDSON-VICK
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| LET93
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| Legacy
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| NULL LEGACY
VALUE
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| C213
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| 01/16/1986
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| 01/16/1986
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| Private
Industry
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| BURROUGHS WELLCOME
CO
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| Signature:
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| BURROUGHS WELLCOME CO
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| C214
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| 01/17/1986
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| 01/17/1986
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| Private
Industry
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| RICHARDSON-VICKS
INC
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| & V14 (2 OF
2)
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| Signature:
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| RICHARDSON-VICKS INC
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| SUP2
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| 02/26/1986
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| 02/26/1986
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| Private
Industry
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| RICHARDSON-VICKS
INC
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| 15
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| - 29 SEE C00214
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| Signature:
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| RICHARDSON-VICKS INC
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| LET94
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| 10/21/1986
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| 10/21/1986
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| Other
Organization
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| HFN-210 (GILBERTSON)
TO VICKS RES CTR
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| SEE C00214
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| LET95
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| 11/07/1986
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| 11/07/1986
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| Other
Organization
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| HFN-210 (GILBERTSON)
TO RICHARDSON -V
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| SEE C00212
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| C215
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| 01/06/1987
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| 12/29/1986
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| Individual
Consumer
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| HACKIE, E
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| CF 81N-0022
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| Signature:
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| HACKIE, E
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| LET96
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| 03/16/1987
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| 03/16/1987
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| Private
Industry
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| RICHARDSON-VICKS
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| SEE C00212
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| LET97
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| 04/20/1987
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| 04/20/1987
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| Private
Industry
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| RICHARDSON-VICKS
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| SEE C00212
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| LET98
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| 07/20/1987
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| 07/20/1987
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| Private
Industry
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| RICHARDSON-VICKS
INC
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| SEE C00212
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| SUP3
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| 08/17/1987
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| 08/17/1987
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| Private
Industry
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| RICHARDSON-VICKS INC
(V 1 OF 1)
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| 30
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| SEE C00214
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| Signature:
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| RICHARDSON-VICKS INC (V 1
O
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| MM6
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| 08/20/1987
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| 08/20/1987
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| Other
Organization
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| HFN-213
(COTHRAN)
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| CF 76N-052G
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| LET99
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| 12/04/1987
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| 12/04/1987
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| Other
Organization
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| GILBERTSON, W
(HFN-210)
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| SEE LET97/LET98
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| CP10
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| 02/16/1988
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| 02/18/1988
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| Private
Industry
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| BEECHAM PROD
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| 10
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| ACK 88/02/18
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| Signature:
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| BEECHAM PROD
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| LET100
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| 06/24/1988
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| 06/24/1988
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| Private
Industry
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| BEECHAM PROD
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| LET101
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| 06/30/1988
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| 06/27/1988
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| Private
Industry
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| BEECHAM PRODS
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| SEE CP0010
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| LET102
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| 08/24/1988
|
| 08/24/1988
|
| Other
Organization
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| PECK, C (HFN-1)
BEECHAM PRODS
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| INT. 88/08/23
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| CP11
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| 10/21/1988
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| 10/24/1988
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| Private
Industry
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| THOMPSON MEDICAL CO
INC CF 81N-0022
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| 10
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| BOOKS IN VOL 32
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| Signature:
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| THOMPSON MEDICAL CO INC CF
81
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| C216
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| 12/12/1988
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| 12/12/1988
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| Private
Industry
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| RICHARDSON-VICKS
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| Signature:
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| RICHARDSON-VICKS
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| LET103
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| 02/08/1989
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| 02/08/1989
|
| Other
Organization
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| GILBERTSON, W
(HFD-210) CF 81N0022
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| INT. 89/02/07
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| Signature:
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| GILBERTSON, W (HFD-210) CF
81
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| CP12
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| 03/14/1989
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| 03/14/1989
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| Private
Industry
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| FLEMING &
CO
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| 10
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| ACK 3/14/89
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| Signature:
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| FLEMING & CO
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| C217
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| 03/24/1989
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| 03/23/1989
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| Private
Industry
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| SCHERING-PLOUGH
CORP
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| Signature:
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| SCHERING-PLOUGH CORP
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| LET104
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| 05/04/1989
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| 05/04/1989
|
| Other
Organization
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| GILBERTSON, W
(HFD-210) SMITHKLINE
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| CF 81N-0022
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| LET105
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| 05/04/1989
|
| 05/04/1989
|
| Other
Organization
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| GILBERTSON, W
(HFD-210) CIBA
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| CF 81N-0022
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| RPT2
|
| 05/15/1989
|
| 05/15/1989
|
| Private
Industry
|
| CIBA
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| 33
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| CF 1981N-0022
|
|
|
| Signature:
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| CIBA
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| SUP4
|
| 05/16/1989
|
| 05/12/1989
|
| Private
Industry
|
| SCHERING-PLOUGH
CORP
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| 10
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| Signature:
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| SCHERING-PLOUGH CORP
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| RPT3
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| 06/05/1989
|
| 06/05/1989
|
| Association
|
| NDMA
|
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| 50
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| 3 vols 50-52
|
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| Signature:
|
| R William Soller PhD
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| RPT4
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| 06/16/1989
|
| 06/16/1989
|
| Private
Industry
|
| SmithKline Consumer
Prods Co
|
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| 53
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| 3 Vols 53-55
|
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| Signature:
|
| Robert G. Kohler Rph JD
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| LET106
|
| 06/16/1989
|
| 06/16/1989
|
| Other
Organization
|
| HFD-210
|
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| PDN1
|
| 07/03/1989
|
| 07/03/1989
|
| Other
Organization
|
| HFC-1
|
|
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| 10
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|
|
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| Signature:
|
| John Taylor
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| APE3
|
| 07/11/1989
|
| 07/11/1989
|
| Private
Industry
|
| Richardson-Vicks
USA/Hlth Care Prods Div
|
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| 10
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| Signature:
|
| Douglas S. Smith
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| RPT5
|
| 08/01/1989
|
| 08/01/1989
|
| Private
Industry
|
| Ciba-Geigy
Corp.
|
|
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| 56
|
| SEE RPT2 1 of1
|
|
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| Signature:
|
| Iris H. Shelton
|
|
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| RPT6
|
| 08/10/1989
|
| 08/10/1989
|
| Private
Industry
|
| CIBA Consumer Pharms
div of CIBA-GEIGY C
|
|
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| 59
|
| VOL 57-59 3vols
|
|
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| Signature:
|
| Linda Ballai Fischer
|
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| RPT7
|
| 09/28/1989
|
| 09/25/1989
|
| Private
Industry
|
| Ciba-Geigy Corp
|
|
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|
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| 10
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| CF81N0022/RPT12
|
|
|
| Signature:
|
| Linda Ballai Fischer
|
|
|
|
|
| LET107
|
| 11/30/1989
|
| 11/30/1989
|
| Other
Organization
|
| HFD-210
|
|
|
|
|
|
|
|
|
| SEE C214
|
|
|
|
|
| LET108
|
| 12/05/1989
|
| 12/05/1989
|
| Other
Organization
|
| HFD-210
|
|
|
|
|
|
|
| 10
|
| INT. 12/1/89
SEE LET101 & CP10
|
|
|
|
|
|
|
| LET109
|
| 12/29/1989
|
| 12/29/1989
|
| Other
Organization
|
| HFD-210
|
|
|
|
|
|
|
|
|
| See
C212,LET95,96,97,98,99
|
|
|
|
|
| CP13
|
| 04/05/1990
|
| 04/05/1990
|
| Private
Industry
|
| Thompson Medical Co.,
Inc. (Vls.60-62)
|
|
|
|
|
|
|
| 62
|
| Ack. 4/5/90 3Vl
|
|
|
| Signature:
|
| H. I. Silverman, D. Sc.
|
|
|
|
|
| LET110
|
| 05/08/1990
|
| 05/08/1990
|
| Other
Organization
|
| HFD-210
|
|
|
|
|
|
|
|
|
| INT 05/02/90
|
|
|
|
|
| SUP5
|
| 07/31/1990
|
| 07/30/1990
|
| Private
Industry
|
| Ciba Consumer
Pharmaceuticals
|
|
|
|
|
|
|
| 64
|
| CF 81N-0022 V65
|
|
|
| Signature:
|
| Linda Ballai Fischer
|
|
|
|
|
| C218
|
| 10/29/1990
|
| 10/26/1990
|
| Association
|
| NDMA
|
|
|
|
|
|
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|
|
| VOL. 66-67
|
|
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|
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| Signature:
|
| R. William Soller, Ph.D.
|
|
|
| CP14
|
| 11/14/1990
|
| 11/15/1990
|
| Private
Industry
|
| Thompson Medical Co.,
Inc.
|
|
|
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|
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| 63
|
| ACK 11/15/90
|
|
|
|
|
| Signature:
|
| Edward L. Steinberg, M.Sc.,
O.D.
|
|
|
|
|
| LET111
|
| 12/24/1990
|
| 12/24/1990
|
| Other
Organization
|
| HFD-210
|
|
|
|
|
|
|
|
|
| INT. 12/17/90
|
|
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|
|
| C219
|
| 01/18/1991
|
| 01/18/1991
|
| Other
Organization
|
| Ron Wyden (CI)
|
|
|
|
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|
|
| ANS 12/10/90
|
|
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| Signature:
|
| Ron Wdden (CI)
|
|
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|
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| PDN2
|
| 01/24/1991
|
| 01/24/1991
|
| Other
Organization
|
| HFC-1
|
|
|
|
|
|
|
| 63
|
| SEE CP10
|
|
|
| Signature:
|
| Ronald G. Chesemore
|
|
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|
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| RPT8
|
| 02/14/1991
|
| 02/11/1991
|
| Private
Industry
|
| Thompson Medical
Company, Inc.
|
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| 69
|
| 1 VOL (SEE CP14
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|
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| Signature:
|
| Harold I. Silverman,
D.Sc.
|
|
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|
|
| C220
|
| 04/23/1992
|
| 04/23/1992
|
| Other
Organization
|
| National
Transportation Safety Board
|
|
|
|
|
|
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|
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|
|
| Signature:
|
| Dr. Bernard S. Loeb
|
|
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|
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| LET112
|
| 04/23/1992
|
| 04/23/1992
|
| Other
Organization
|
| HFD-810
|
|
|
|
|
|
|
|
|
| SEE C220
|
|
|
|
|
| REF1
|
| 05/01/1992
|
| 05/01/1992
|
| Association
|
| NDMA
|
|
|
|
|
|
|
| 63
|
|
|
|
|
|
|
| Signature:
|
| R. William Soller, Ph.D.
|
|
|
| NPR2
|
|
|
| 06/18/1992
|
| FDA
|
| FDA
|
|
|
|
|
| 08/18/1992
|
| 63
|
|
|
|
|
|
|
| Signature:
|
| FDA
|
|
|
|
|
| C221
|
| 07/22/1992
|
| 07/20/1992
|
| Individual
Consumer
|
| Robert D. Laird,
M.D.
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Robert D. Laird, M.D.
|
|
|
|
|
| NCR1
|
|
|
| 07/29/1992
|
| FDA
|
| FDA
|
|
|
|
|
| 08/18/1992
|
| 63
|
|
|
|
|
| Signature:
|
| FDA
|
|
|
|
|
| MT10
|
| 08/05/1992
|
| 08/05/1992
|
| Other
Organization
|
| HFD-813
|
|
|
|
|
|
|
| 63
|
|
|
|
|
| Signature:
|
| Katharine A. Freeman
|
|
|
|
|
| NEC1
|
|
|
| 08/05/1992
|
| FDA
|
| FDA
|
|
|
|
|
| 10/05/1992
|
| 63
|
|
|
|
|
| Signature:
|
| FDA
|
|
|
|
|
| LET113
|
| 10/05/1992
|
| 10/05/1992
|
| Private
Industry
|
| Somerset
Pharmceuticals, Inc.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| C222
|
| 10/06/1992
|
| 10/05/1992
|
| Association
|
| Nonprescription Drug
Manufacturers Assn.
|
|
|
|
|
|
|
|
|
| Vol. 1 of 1
CF 90N-0420, 91N- 0323
|
|
|
| Signature:
|
| R. William Soller, Ph.D
|
|
|
|
|
|
|
|
|
| C223
|
| 10/16/1992
|
| 10/12/1992
|
| Association
|
| NDMA
|
|
|
|
|
|
|
|
|
| CF 91N-0323,
90N- 0420
|
|
|
| Signature:
|
| R. William Soller, Ph.D.
|
|
|
|
|
|
|
|
|
| C224
|
| 12/18/1992
|
| 12/18/1992
|
| Private
Industry
|
| Somerset
Pharmaceuticals, Inc.
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Patricia A. Dahlin,
Pharm.D.
|
|
|
|
|
| C225
|
| 02/01/1993
|
| 02/01/1993
|
| Association
|
| NDMA
|
|
|
|
|
|
|
|
|
| CF 81N-0022
|
|
|
| Signature:
|
| R. William Soller, Ph.D.
|
|
|
|
|
| C226
|
| 11/05/1993
|
| 11/05/1993
|
| Association
|
| NDMA, Nonprescription
Drug Mfrs Assn.
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| R. William Soller, Ph.D.
|
|
|
| MM7
513 (e) Reclassification
of Tissue Adhesive For Soft Tissue Approximation
|
| 11/05/1993
|
| 11/05/1993
|
| Other
Organization
|
| HFD-814
|
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| Robert Sherman
|
|
|
|
|
| LET114
|
| 03/28/1994
|
| 03/28/1994
|
| Other
Organization
|
| HFD-820
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| LET115
|
| 03/28/1994
|
| 03/28/1994
|
| Other
Organization
|
| HFD-820
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| PR2
|
| 04/15/1994
|
| 04/15/1994
|
| Association
|
| NDMA, Nonprescription
Drug Mfrs Assn.
|
|
|
|
|
|
|
|
|
| CF 81N-0022
|
|
|
| Signature:
|
| R. William Soller, Ph.D.
|
|
|
|
|
| NFR1
|
|
|
| 08/22/1994
|
| FDA
|
| FDA
|
| 03/08/1996
|
| 9570-9571
|
|
|
| 63
|
| 04NFM Vol 71 Eff.
8/23/95
|
|
|
| Signature:
|
| HUBBARD, WILLIAM
|
|
|
|
|
| CP15
|
| 08/26/1994
|
| 08/26/1994
|
| Private
Industry
|
| Caprice-Greystoke,
Ltd.
|
|
|
|
|
|
|
| 72
|
| ACK 8/26/94 CF
81N-0022
|
|
|
| Signature:
|
| John Spector
|
|
|
|
|
| AMD1
|
| 09/21/1994
|
| 09/21/1994
|
| Private
Industry
|
| Caprice-Greystoke,
Ltd.
|
|
|
|
|
|
|
| 73
|
| See CP15/CF
|
|
|
| Signature:
|
| John Spector
|
|
|
|
|
| C227
|
| 10/12/1994
|
| 10/12/1994
|
| Private
Industry
|
| Caprice-Greystoke,
Ltd.
|
|
|
|
|
|
|
| 73
|
| See CP15/CF
|
|
|
|
|
| Signature:
|
| John Spector
|
|
|
| LET116
|
| 10/17/1994
|
| 10/17/1994
|
| Private
Industry
|
| Caprice-Greystoke,
Ltd.
|
|
|
|
|
|
|
| pdf
|
| See CP15/CF
|
|
|
|
|
| Signature:
|
| John Spector
|
|
|
|
|
| LET117
|
| 12/28/1994
|
| 12/28/1994
|
| Other
Organization
|
| HFD-810
|
|
|
|
|
|
|
| pdf
|
| SEE CP15 Closed
|
|
|
| Signature:
|
| William E. Gilbertson,
Pharm.D
|
|
|
|
|
| CP16
|
| 12/12/1995
|
| 12/12/1995
|
| Private
Industry
|
| Caprice-Greystoke,
Ltd.
|
|
|
|
|
|
|
| 74
|
| ACK 12/12/95
CF81N-0022
|
|
|
| Signature:
|
| John Spector, C.E.O.
|
|
|
|
|
| NSA1
|
|
|
| 03/07/1996
|
| FDA
|
| FDA
|
| 03/08/1996
|
| 9570-9571
|
| 09/09/1996
|
| 73
|
| EFF 08/31/95
|
|
|
| Signature:
|
| HUBBARD, WILLIAM
|
|
|
|
|
| PAV4
|
| 05/24/1996
|
| 05/24/1996
|
| Other
Organization
|
| HFC-1
|
|
|
|
|
|
|
| pdf
|
| SEE CP16 PDN
INPART
|
|
|
| Signature:
|
| Ronald G. Chesemore
|
|
|
|
|
| LET118
|
| 04/10/1997
|
| 04/10/1997
|
| Other
Organization
|
| HFD-5
|
|
|
|
|
|
|
| pdf
AttachmentA
AttachmentB
|
| SEE CP16
|
|
|
| Signature:
|
| Jane Axelrad
| |
|
|
|
|
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October 22, 2007
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