Application 061392
- Type
- ANDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PRINCIPEN | AMPICILLIN/AMPICILLIN TRIHYDRATE | CAPSULE;ORAL | EQ 250MG BASE | No | No |
| 002 | PRINCIPEN | AMPICILLIN/AMPICILLIN TRIHYDRATE | CAPSULE;ORAL | EQ 500MG BASE | No | No |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A061392-001 | PRINCIPEN | AMPICILLIN/AMPICILLIN TRIHYDRATE | EQ 250MG BASE | CAPSULE / ORAL | | Approved before 1982 | |
| A061392-002 | PRINCIPEN | AMPICILLIN/AMPICILLIN TRIHYDRATE | EQ 500MG BASE | CAPSULE / ORAL | | Approved before 1982 | |