Application 085056
- Type
- ANDA
- Sponsor
- ORTHO MCNEIL PHARM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TYLENOL W/ CODEINE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | TYLENOL W/ CODEINE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 003 | TYLENOL W/ CODEINE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 325MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 004 | TYLENOL W/ CODEINE | ACETAMINOPHEN; CODEINE PHOSPHATE | TABLET;ORAL | 325MG;60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |