Application 200651
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| 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 | Labeler | Marketing category | Status |
|---|
| 0904-6823 | Gabapentin | Gabapentin | Major Pharmaceuticals | ANDA | Current |
| 0904-6823 | Gabapentin | Gabapentin | Major Pharmaceuticals | ANDA | Current |
| 0904-6823 | Gabapentin | Gabapentin | Major Pharmaceuticals | ANDA | Current |
| 0904-6823 | Gabapentin | Gabapentin | Major Pharmaceuticals | ANDA | Current |
| 0904-7108 | Gabapentin | Gabapentin | Major Pharmaceuticals | ANDA | Current |
| 0904-7108 | Gabapentin | Gabapentin | Major Pharmaceuticals | ANDA | Current |
| 16714-330 | Gabapentin | Gabapentin | NorthStar Rx LLC | ANDA | Current |
| 16714-330 | Gabapentin | Gabapentin | NorthStar Rx LLC | ANDA | Current |
| 16714-330 | Gabapentin | Gabapentin | NorthStar Rx LLC | ANDA | Current |
| 16714-330 | Gabapentin | Gabapentin | NorthStar Rx LLC | ANDA | Current |
| 16714-330 | Gabapentin | Gabapentin | NorthStar Rx LLC | ANDA | Current |
| 16714-330 | Gabapentin | Gabapentin | NorthStar Rx LLC | ANDA | Current |
| 16714-332 | Gabapentin | Gabapentin | NorthStar Rx LLC | ANDA | Current |
| 16714-332 | Gabapentin | Gabapentin | NorthStar Rx LLC | ANDA | Current |
| 16714-332 | Gabapentin | Gabapentin | NorthStar Rx LLC | ANDA | Current |
| 16714-332 | Gabapentin | Gabapentin | NorthStar Rx LLC | ANDA | Current |
| 16714-332 | Gabapentin | Gabapentin | NorthStar Rx LLC | ANDA | Current |
| 16714-332 | Gabapentin | Gabapentin | NorthStar Rx LLC | ANDA | Current |
| 33261-051 | Gabapentin | Gabapentin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-116 | Gabapentin | Gabapentin | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 42292-024 | Gabapentin | Gabapentin | Mylan Institutional Inc. | ANDA | Current |
| 42292-025 | Gabapentin | Gabapentin | Mylan Institutional Inc. | ANDA | Current |
| 42292-025 | Gabapentin | Gabapentin | Mylan Institutional Inc. | ANDA | Current |
| 55154-3357 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 55154-3357 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 55154-3366 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 63187-148 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 63187-148 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 63629-6339 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6339 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6442 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6442 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6442 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6442 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 65862-523 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-523 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-523 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-523 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-523 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-523 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-523 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-523 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-523 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-524 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-524 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-524 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-524 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-524 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-524 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-524 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-524 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-524 | Gabapentin | Gabapentin | Aurobindo Pharma Limited | ANDA | Current |
| 68788-9923 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-2323 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2323 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2323 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2323 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2356 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2356 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2356 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2356 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2356 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2616 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2616 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2616 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2616 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2616 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2616 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70934-636 | Gabapentin | Gabapentin | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 72189-092 | GABAPENTIN | GABAPENTIN | DIRECT RX | ANDA | Current |
| 80425-0036 | Neurontin | Gabapentin 800mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0036 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0036 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0036 | Neurontin | Gabapentin 800mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0097 | Neurontin | Gabapentin 600mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0097 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0097 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0097 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0158 | Neurontin | Gabapentin 800mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0158 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |