Application 077242
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 100MG | No | No |
| 002 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 300MG | No | No |
| 003 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 400MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 45861-111 | GABAPENTIN | GABAPENTIN | Pharmaceutica North America, Inc. | ANDA | Current |
| 50090-0895 | gabapentin | gabapentin | A-S Medication Solutions | ANDA | Current |
| 50090-0948 | gabapentin | gabapentin | A-S Medication Solutions | ANDA | Current |
| 61919-101 | GABAPENTIN | GABAPENTIN | Direct Rx | ANDA | Current |
| 61919-102 | Gabapentin | Gabapentin | Direct Rx | ANDA | Current |
| 61919-102 | GABAPENTIN | GABAPENTIN | Direct Rx | ANDA | Current |
| 61919-492 | GABAPENTIN | GABAPENTIN | Direct Rx | ANDA | Current |
| 62756-137 | gabapentin | gabapentin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-137 | gabapentin | gabapentin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-137 | gabapentin | gabapentin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-138 | gabapentin | gabapentin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-138 | gabapentin | gabapentin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-138 | gabapentin | gabapentin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-139 | gabapentin | gabapentin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-139 | gabapentin | gabapentin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-139 | gabapentin | gabapentin | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 64725-0138 | GABAPENTIN | GABAPENTIN | TYA Pharmaceuticals | ANDA | Current |