FdaApplication
ANDA 085056
Identifiers
- fda_app_no: ANDA085056
Properties
| Property | Value |
|---|---|
| applicant_name | ORTHO MCNEIL PHARMACEUTICAL INC |
| application_type | ANDA |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| TYLENOL W/ CODEINE | ACETAMINOPHEN; CODEINE PHOSPHATE | 325MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| TYLENOL W/ CODEINE | ACETAMINOPHEN; CODEINE PHOSPHATE | 325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| TYLENOL W/ CODEINE | ACETAMINOPHEN; CODEINE PHOSPHATE | 325MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
| TYLENOL W/ CODEINE | ACETAMINOPHEN; CODEINE PHOSPHATE | 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL |
4 products