Application 076017
- Type
- ANDA
- Sponsor
- IVAX SUB TEVA PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GABAPENTIN | GABAPENTIN | TABLET;ORAL | 100MG | No | No |
| 002 | GABAPENTIN | GABAPENTIN | TABLET;ORAL | 300MG | No | No |
| 003 | GABAPENTIN | GABAPENTIN | TABLET;ORAL | 400MG | No | No |
| 004 | GABAPENTIN | GABAPENTIN | TABLET;ORAL | 600MG | No | No |
| 005 | 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 |
|---|
| 0093-4443 | Gabapentin | Gabapentin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-4444 | Gabapentin | Gabapentin | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 50436-7286 | Gabapentin | Gabapentin | Unit Dose Services | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 8849 | ORIG | 2004-04-29 |