Application 077802
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OXCARBAZEPINE | OXCARBAZEPINE | TABLET;ORAL | 150MG | No | No |
| 002 | OXCARBAZEPINE | OXCARBAZEPINE | TABLET;ORAL | 300MG | No | No |
| 003 | OXCARBAZEPINE | OXCARBAZEPINE | TABLET;ORAL | 600MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 21695-862 | Oxcarbazepine | Oxcarbazepine | Rebel Distributors Corp | ANDA | Current |
| 21695-863 | Oxcarbazepine | Oxcarbazepine | Rebel Distributors Corp | ANDA | Current |
| 21695-864 | Oxcarbazepine | Oxcarbazepine | Rebel Distributors Corp | ANDA | Current |
| 50090-3961 | Oxcarbazepine | Oxcarbazepine | A-S Medication Solutions | ANDA | Current |
| 55700-569 | Oxcarbazepine | Oxcarbazepine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 61919-569 | TRILEPTAL | OXCARBAZEPINE | DIRECT RX | ANDA | Current |
| 64725-0137 | Oxcarbazepine | Oxcarbazepine | TYA Pharmaceuticals | ANDA | Current |
| 68462-137 | Oxcarbazepine | Oxcarbazepine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-137 | Oxcarbazepine | Oxcarbazepine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-137 | Oxcarbazepine | Oxcarbazepine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-137 | Oxcarbazepine | Oxcarbazepine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-138 | Oxcarbazepine | Oxcarbazepine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-138 | Oxcarbazepine | Oxcarbazepine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-138 | Oxcarbazepine | Oxcarbazepine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-138 | Oxcarbazepine | Oxcarbazepine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-139 | Oxcarbazepine | Oxcarbazepine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-139 | Oxcarbazepine | Oxcarbazepine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-139 | Oxcarbazepine | Oxcarbazepine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-139 | Oxcarbazepine | Oxcarbazepine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 70518-3127 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-3127 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-3197 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-3197 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 70518-3237 | Oxcarbazepine | Oxcarbazepine | REMEDYREPACK INC. | ANDA | Current |
| 71205-411 | Oxcarbazepine | Oxcarbazepine | Proficient Rx LP | ANDA | Current |
| 71205-411 | Oxcarbazepine | Oxcarbazepine | Proficient Rx LP | ANDA | Current |
| 71335-0144 | Oxcarbazepine | Oxcarbazepine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0410 | Oxcarbazepine | Oxcarbazepine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0978 | Oxcarbazepine | Oxcarbazepine | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 24168 | ORIG | 2007-10-23 |
| 39542 | ORIG | 2007-10-10 |
| 9086 | ORIG | 2007-10-10 |