Application 075726
- Type
- ANDA
- Sponsor
- MALLINCKRODT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PEMOLINE | PEMOLINE | TABLET;ORAL | 75MG | No | No |
| 002 | PEMOLINE | PEMOLINE | TABLET;ORAL | 37.5MG | No | No |
| 003 | PEMOLINE | PEMOLINE | TABLET;ORAL | 18.75MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8776 | ORIG | 2001-03-30 |