Document type:
NDA (ND)
Company:
Schering Corp.
Company Type:
Drug Manufacturer; Drixoral
56
pages.
10/21/1987
Document type:
EIR (EI)
Company:
Alan B. Sandler, M.D.; Indiana University Hospital
Company Type:
Clinical Investigator; Drug
21
pages.
1/5/1996
Document type:
483 (FE)
Company:
John Nemunaitis, M.D.; Texas Oncology P.A.
Company Type:
Clinical Investigator; Drug
1
pages.
4/1/1996
Document type:
EIR (EI)
Company:
John J. Nemunaitis, M.D.
Company Type:
Clinical Investigator; Drug
11
pages.
4/2/1996
Document type:
Letter (LR)
Company:
John Nemunaitis, M.D.; Texas Oncology P.A.
Company Type:
Clinical Investigator; Drug
2
pages.
4/30/1996
Document type:
EIR (EI)
Company:
New York Blood Services
Company Type:
Blood Product Provider
35
pages.
12/20/1996
Document type:
Warning Letter (WL)
Company:
Hoffmann-La Roche, Inc.
Company Type:
Pharmaceutical Manufacturer
3
pages.
1/5/1998
Document type:
Warning Letter (WL)
Company:
Hoffmann-La Roche, Inc.
Company Type:
Pharmaceutical Manufacturer
4
pages.
1/27/1998
Document type:
Warning Letter (WL)
Company:
Hoffmann-La Roche, Inc.
Company Type:
Pharmaceutical Manufacturer
4
pages.
3/5/1998
Document type:
483 (FE)
Company:
John Nemunaitis, M.D.; Texas Oncology P.A.
Company Type:
Clinical Investigator; Drug
2
pages.
4/13/1998
Document type:
EIR (EI)
Company:
John Nemunaitis, M.D.; Texas Oncology P.A.
Company Type:
Clinical Investigator; Drug
18
pages.
4/13/1998
Document type:
EIR (EI)
Company:
Hamilton Company
Company Type:
Medical Device Manufacturer
3
pages.
4/30/1998
Document type:
483 (FE)
Company:
Time Cap Labs, Inc.
Company Type:
Finished Pharmaceutical Manufactuer
11
pages.
5/5/1998
Document type:
EIR (EI)
Company:
Hunt Wesson Inc.
Company Type:
Food Manufacturer
5
pages.
5/6/1998
Document type:
483 (FE)
Company:
Alan B. Sandler, M.D.
Company Type:
Clinical Investigator; Drug
3
pages.
5/22/1998
Document type:
Letter (LR)
Company:
John Nemunaitis, M.D.; Texas Oncology P.A.
Company Type:
Clinical Investigator; Drug
1
pages.
8/25/1998
Document type:
483 (FE)
Company:
Forest-Inwood Laboratories, Inc.
Company Type:
Bioanalytical Laboratory
6
pages.
10/23/1998
Document type:
483 (FE)
Company:
South China Seafood Company
Company Type:
Seafood Processor
1
pages.
1/13/1999
Document type:
Letter (LR)
Company:
South China Seafood Company
Company Type:
Seafood Importer, Distributor
3
pages.
2/11/1999
Document type:
EIR (EI)
Company:
Roy S. Feldman, D.D.S.; Philadelphia Veteran Affairs Medical Center
Company Type:
Clinical Investigator; Drug
9
pages.
3/1/1999
Document type:
483 (FE)
Company:
Roy S. Feldman, D.D.S.; Philadelphia Veteran Affairs Medical Center
Company Type:
Clinical Investigator; Drug
1
pages.
3/1/1999
Document type:
Response (RE)
Company:
South China Seafood Company
Company Type:
Seafood Importer, Distributor
1
pages.
3/15/1999
Document type:
EIR (EI)
Company:
Saleem Ahmad M.D.
Company Type:
Medical Device Investigator
8
pages.
4/21/1999
Document type:
Letter (LR)
Company:
Roy S. Feldman, D.D.S.; Philadelphia Veteran Affairs Medical Center
Company Type:
Clinical Investigator; Drug
1
pages.
5/8/1999
Document type:
Warning Letter (WL)
Company:
Hoffmann-La Roche, Inc.
Company Type:
Pharmaceutical Manufacturer
9
pages.
12/17/1999
Document type:
EIR (EI)
Company:
David M. Pariser, M.D.; Virginia Clinical Research
Company Type:
Clinical Investigator; Drug
4
pages.
3/2/2000
Document type:
483 (FE)
Company:
David M. Pariser, M.D.; Virginia Clinical Research
Company Type:
Clinical Investigator; Drug
2
pages.
3/2/2000
Document type:
483 (FE)
Company:
Hartford Hospital
Company Type:
Clinical Investigator
2
pages.
3/2/2000
Document type:
Warning Letter (WL)
Company:
James M. Wilson, M.D.; Institute for Human Gene Therapy
Company Type:
Clinical Investigator (Drug)
20
pages.
3/3/2000
Document type:
Response (RE)
Company:
David M. Pariser, M.D.; Virginia Clinical Research
Company Type:
Clinical Investigator; Drug
3
pages.
3/7/2000
Document type:
483 (FE)
Company:
Schering-Plough Products, LLC
Company Type:
Human and Veterinary Drug Manufacturer
5
pages.
3/28/2000
Document type:
EIR (EI)
Company:
Kelly B. Pendergrass M.D.
Company Type:
Clinical Investigator, Drug
3
pages.
4/6/2000
Document type:
EIR (EI)
Company:
John J. Nemunaitis, M.D.
Company Type:
Clinical Investigator; Drug
3
pages.
6/2/2000
Document type:
483 (FE)
Company:
Holy Cross Hospital
Company Type:
Institutional Review Board
4
pages.
6/15/2000
Document type:
Misc. (MI)
Company:
Hunt Wesson Inc.
Company Type:
Food Manufacturer
1
pages.
7/18/2000
Document type:
EIR (EI)
Company:
ConAgra Foods
Company Type:
Food Manufacturer
3
pages.
7/25/2000
Document type:
Warning Letter (WL)
Company:
Hoffmann-La Roche, Inc.
Company Type:
Pharmaceutical Manufacturer
5
pages.
7/31/2000
Document type:
EIR (EI)
Company:
ConAgra Foods
Company Type:
Food Manufacturer
2
pages.
8/3/2000
Document type:
EIR (EI)
Company:
ConAgra Foods
Company Type:
Food Manufacturer
1
pages.
8/3/2000
Document type:
EIR (EI)
Company:
Kansas City Analytical Services
Company Type:
Contract Laboratory
8
pages.
10/5/2000
Document type:
Misc. (MI)
Company:
James M. Wilson, M.D.; Institute for Human Gene Therapy
Company Type:
Clinical Investigator (Drug)
15
pages.
11/30/2000
Document type:
483 (FE)
Company:
Schering-Plough Products, LLC
Company Type:
Pharmaceutical Manufacturer
5
pages.
12/14/2000
Document type:
483 (FE)
Company:
Haifa Smoked Fish
Company Type:
Seafood Processor
1
pages.
1/31/2001
Document type:
Letter (LR)
Company:
John J. Nemunaitis, M.D.
Company Type:
Clinical Investigator; Drug
1
pages.
2/12/2001
Document type:
483 (FE)
Company:
McNeil Consumer Healthcare Inc.
Company Type:
Drug Manufacturer
1
pages.
2/13/2001
Document type:
483 (FE)
Company:
Schering-Plough Products, LLC
Company Type:
Pharmaceutical Manufacturer
10
pages.
2/16/2001
Document type:
483 (FE)
Company:
Schering-Plough Products, LLC
Company Type:
Pharmaceutical Manufacturer
5
pages.
2/16/2001
Document type:
483 (FE)
Company:
Eli Lilly & Company
Company Type:
Pharmaceutical Manufacturer
25
pages.
2/23/2001
Document type:
Warning Letter (WL)
Company:
Eli Lilly and Company
Company Type:
Drug Manufacturer
3
pages.
3/2/2001
Document type:
Letter (LR)
Company:
Eli Lilly & Company
Company Type:
Pharmaceutical Manufacturer
2
pages.
3/8/2001