Application 077684
- Type
- ANDA
- Sponsor
- BARR LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRETINOIN | TRETINOIN | CAPSULE;ORAL | 10MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0555-0808 | Tretinoin | Tretinoin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0808 | Tretinoin | Tretinoin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0808 | Tretinoin | Tretinoin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0808 | Tretinoin | Tretinoin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 63629-8752 | Tretinoin | Tretinoin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8752 | Tretinoin | Tretinoin | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9076 | ORIG | 2007-07-05 |