Application 083266
- Type
- ANDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMNESTROGEN | ESTROGENS, ESTERIFIED | TABLET;ORAL | 0.3MG | No | No |
| 002 | AMNESTROGEN | ESTROGENS, ESTERIFIED | TABLET;ORAL | 0.625MG | No | No |
| 003 | AMNESTROGEN | ESTROGENS, ESTERIFIED | TABLET;ORAL | 1.25MG | No | No |
| 004 | AMNESTROGEN | ESTROGENS, ESTERIFIED | TABLET;ORAL | 2.5MG | 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 |
|---|
| A083266-001 | AMNESTROGEN | ESTROGENS, ESTERIFIED | 0.3MG | TABLET / ORAL | | Approved before 1982 | |
| A083266-002 | AMNESTROGEN | ESTROGENS, ESTERIFIED | 0.625MG | TABLET / ORAL | | Approved before 1982 | |
| A083266-003 | AMNESTROGEN | ESTROGENS, ESTERIFIED | 1.25MG | TABLET / ORAL | | Approved before 1982 | |
| A083266-004 | AMNESTROGEN | ESTROGENS, ESTERIFIED | 2.5MG | TABLET / ORAL | | Approved before 1982 | |