Application 087811
- Type
- ANDA
- Sponsor
- VALEANT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PHRENILIN | ACETAMINOPHEN; BUTALBITAL | TABLET;ORAL | 325MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 53923 | ORIG | 2018-05-01 |