Application 075694
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
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 |
|---|---|---|---|---|---|
| 0228-2636 | Gabapentin | Gabapentin | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2636 | Gabapentin | Gabapentin | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2636 | Gabapentin | Gabapentin | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2636 | Gabapentin | Gabapentin | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2636 | Gabapentin | Gabapentin | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2636 | Gabapentin | Gabapentin | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2637 | Gabapentin | Gabapentin | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2637 | Gabapentin | Gabapentin | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2637 | Gabapentin | Gabapentin | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2637 | Gabapentin | Gabapentin | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2637 | Gabapentin | Gabapentin | Actavis Pharma, Inc. | ANDA | Current |
| 0228-2637 | Gabapentin | Gabapentin | Actavis Pharma, Inc. | ANDA | Current |
| 0615-6548 | Gabapentin | Gabapentin | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-6554 | Gabapentin | Gabapentin | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-6586 | Gabapentin | Gabapentin | Major Pharmaceuticals | ANDA | Current |
| 0904-6586 | Gabapentin | Gabapentin | Major Pharmaceuticals | ANDA | Current |
| 55154-7989 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 55154-7989 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 63187-006 | Gabapentin | Gabapentin | Proficient Rx | ANDA | Current |
| 63187-006 | Gabapentin | Gabapentin | Proficient Rx | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 24154 | ORIG | 2008-02-01 |