Application 078926
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GABAPENTIN | GABAPENTIN | TABLET;ORAL | 600MG | No | No |
| 002 | GABAPENTIN | GABAPENTIN | TABLET;ORAL | 800MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43063-611 | Gabapentin | Gabapentin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-611 | Gabapentin | Gabapentin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-611 | Gabapentin | Gabapentin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-611 | Gabapentin | Gabapentin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-3912 | Gabapentin | Gabapentin | A-S Medication Solutions | ANDA | Current |
| 50090-3912 | Gabapentin | Gabapentin | A-S Medication Solutions | ANDA | Current |
| 50090-3915 | Gabapentin | Gabapentin | A-S Medication Solutions | ANDA | Current |
| 50090-3915 | Gabapentin | Gabapentin | A-S Medication Solutions | ANDA | Current |
| 55154-7132 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 55154-7132 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 55154-7132 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 55154-7132 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 55154-7149 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 55154-7149 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 55154-7149 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 55154-8189 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 55154-8189 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 55154-8189 | Gabapentin | Gabapentin | Cardinal Health 107, LLC | ANDA | Current |
| 55154-8193 | Gabapentin | Gabapentin | Cardinal Health 107, LLC | ANDA | Current |
| 55154-8193 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 60687-507 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 60687-507 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 60687-507 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 60687-507 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 60687-518 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 60687-518 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 60687-518 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 60687-518 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 61919-104 | GABAPENTIN | GABAPENTIN | DIRECT RX | ANDA | Current |
| 63739-560 | Gabapentin | Gabapentin | McKesson Corporation | ANDA | Current |
| 63739-560 | Gabapentin | Gabapentin | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-560 | Gabapentin | Gabapentin | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-560 | Gabapentin | Gabapentin | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-560 | Gabapentin | Gabapentin | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 65841-705 | Gabapentin | Gabapentin | Zydus Lifesciences Limited | ANDA | Current |
| 65841-705 | Gabapentin | Gabapentin | Cadila Healthcare Limited | ANDA | Current |
| 65841-705 | Gabapentin | Gabapentin | Cadila Healthcare Limited | ANDA | Current |
| 65841-705 | Gabapentin | Gabapentin | Cadila Healthcare Limited | ANDA | Current |
| 65841-706 | Gabapentin | Gabapentin | Zydus Lifesciences Limited | ANDA | Current |
| 65841-706 | Gabapentin | Gabapentin | Cadila Healthcare Limited | ANDA | Current |
| 65841-706 | Gabapentin | Gabapentin | Cadila Healthcare Limited | ANDA | Current |
| 65841-706 | Gabapentin | Gabapentin | Cadila Healthcare Limited | ANDA | Current |
| 68001-006 | Gabapentin | Gabapentin | BluePoint Laboratories | ANDA | Current |
| 68001-006 | Gabapentin | Gabapentin | BluePoint Laboratories | ANDA | Current |
| 68001-007 | Gabapentin | Gabapentin | BluePoint Laboratories | ANDA | Current |
| 68001-007 | Gabapentin | Gabapentin | BluePoint Laboratories | ANDA | Current |
| 68084-797 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 68084-797 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 68084-802 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 68084-802 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 68382-204 | Gabapentin | Gabapentin | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-204 | Gabapentin | Gabapentin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-204 | Gabapentin | Gabapentin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-204 | Gabapentin | Gabapentin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-205 | Gabapentin | Gabapentin | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-205 | Gabapentin | Gabapentin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-205 | Gabapentin | Gabapentin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-205 | Gabapentin | Gabapentin | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 72789-127 | Gabapentin | Gabapentin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-127 | Gabapentin | Gabapentin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-127 | Gabapentin | Gabapentin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-127 | Gabapentin | Gabapentin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |