Application 204003
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 50MG BASE | No | No |
| 002 | DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 100MG BASE | No | No |
| 003 | DESVENLAFAXINE SUCCINATE | DESVENLAFAXINE SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 25MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-540 | Desvenlafaxine | Desvenlafaxine Succinate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-540 | Desvenlafaxine | Desvenlafaxine Succinate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-541 | Desvenlafaxine | Desvenlafaxine Succinate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-541 | Desvenlafaxine | Desvenlafaxine Succinate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-542 | Desvenlafaxine | Desvenlafaxine Succinate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-542 | Desvenlafaxine | Desvenlafaxine Succinate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 50090-5274 | Desvenlafaxine | Desvenlafaxine Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-5293 | Desvenlafaxine | Desvenlafaxine Succinate | A-S Medication Solutions | ANDA | Current |
| 51991-006 | Desvenlafaxine | Desvenlafaxine Succinate | Breckenridge Pharmaceutical, Inc | ANDA | Current |
| 51991-006 | Desvenlafaxine | Desvenlafaxine Succinate | Breckenridge Pharmaceutical, Inc | ANDA | Current |
| 51991-006 | Desvenlafaxine | Desvenlafaxine Succinate | Breckenridge Pharmaceutical, Inc | ANDA | Current |
| 51991-006 | Desvenlafaxine | Desvenlafaxine Succinate | Breckenridge Pharmaceutical, Inc | ANDA | Current |
| 51991-006 | Desvenlafaxine | Desvenlafaxine Succinate | Breckenridge Pharmaceutical, Inc | ANDA | Current |
| 51991-311 | Desvenlafaxine | Desvenlafaxine Succinate | Breckenridge Pharmaceutical, Inc | ANDA | Current |
| 51991-311 | Desvenlafaxine | Desvenlafaxine Succinate | Breckenridge Pharmaceutical, Inc | ANDA | Current |
| 51991-311 | Desvenlafaxine | Desvenlafaxine Succinate | Breckenridge Pharmaceutical, Inc | ANDA | Current |
| 51991-311 | Desvenlafaxine | Desvenlafaxine Succinate | Breckenridge Pharmaceutical, Inc | ANDA | Current |
| 51991-311 | Desvenlafaxine | Desvenlafaxine Succinate | Breckenridge Pharmaceutical, Inc | ANDA | Current |
| 51991-312 | Desvenlafaxine | Desvenlafaxine Succinate | Breckenridge Pharmaceutical, Inc | ANDA | Current |
| 51991-312 | Desvenlafaxine | Desvenlafaxine Succinate | Breckenridge Pharmaceutical, Inc | ANDA | Current |
| 51991-312 | Desvenlafaxine | Desvenlafaxine Succinate | Breckenridge Pharmaceutical, Inc | ANDA | Current |
| 51991-312 | Desvenlafaxine | Desvenlafaxine Succinate | Breckenridge Pharmaceutical, Inc | ANDA | Current |
| 51991-312 | Desvenlafaxine | Desvenlafaxine Succinate | Breckenridge Pharmaceutical, Inc | ANDA | Current |
| 55700-577 | Desvenlafaxine | Desvenlafaxine Succinate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 63629-7525 | Desvenlafaxine | Desvenlafaxine Succinate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7525 | Desvenlafaxine | Desvenlafaxine Succinate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7525 | Desvenlafaxine | Desvenlafaxine Succinate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7525 | Desvenlafaxine | Desvenlafaxine Succinate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7559 | Desvenlafaxine | Desvenlafaxine Succinate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7559 | Desvenlafaxine | Desvenlafaxine Succinate | Bryant Ranch Prepack | ANDA | Current |
| 63629-7559 | Desvenlafaxine | Desvenlafaxine Succinate | Bryant Ranch Prepack | ANDA | Current |
| 68071-2704 | Desvenlafaxine | Desvenlafaxine Succinate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7175 | Desvenlafaxine | Desvenlafaxine Succinate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7175 | Desvenlafaxine | Desvenlafaxine Succinate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7175 | Desvenlafaxine | Desvenlafaxine Succinate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7175 | Desvenlafaxine | Desvenlafaxine Succinate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7175 | Desvenlafaxine | Desvenlafaxine Succinate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7194 | Desvenlafaxine | Desvenlafaxine Succinate | Preferred Pharmaceutical, Inc. | ANDA | Current |
| 68788-7194 | Desvenlafaxine | Desvenlafaxine Succinate | Preferred Pharmaceutical, Inc. | ANDA | Current |
| 68788-7194 | Desvenlafaxine | Desvenlafaxine Succinate | Preferred Pharmaceutical, Inc. | ANDA | Current |
| 68788-7194 | Desvenlafaxine | Desvenlafaxine Succinate | Preferred Pharmaceutical, Inc. | ANDA | Current |
| 68788-7194 | Desvenlafaxine | Desvenlafaxine Succinate | Preferred Pharmaceutical, Inc. | ANDA | Current |
| 70518-2495 | Desvenlafaxine | Desvenlafaxine Succinate | REMEDYREPACK INC. | ANDA | Current |
| 71205-586 | Desvenlafaxine | Desvenlafaxine Succinate | Proficient Rx LP | ANDA | Current |
| 71335-2130 | Desvenlafaxine | Desvenlafaxine Succinate | Bryant Ranch Prepack | ANDA | Current |
| 72189-147 | desvenlafaxine | desvenlafaxine succinate | DIRECT RX | ANDA | Current |
| 72189-147 | desvenlafaxine | desvenlafaxine succinate | DIRECT RX | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32489 | ORIG | 2015-07-08 |