Application 089685
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PERPHENAZINE | PERPHENAZINE | TABLET;ORAL | 8MG | No | No |
| 002 | PERPHENAZINE | PERPHENAZINE | TABLET;ORAL | 2MG | No | No |
| 003 | PERPHENAZINE | PERPHENAZINE | TABLET;ORAL | 4MG | No | No |
| 004 | PERPHENAZINE | PERPHENAZINE | TABLET;ORAL | 16MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-1046 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 0781-1047 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 0781-1048 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 0781-1049 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 0781-8046 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 0781-8046 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 0781-8046 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 0781-8047 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 0781-8047 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 0781-8047 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 0781-8048 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 0781-8048 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 0781-8048 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 0781-8049 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 0781-8049 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 0781-8049 | Perphenazine | Perphenazine | Sandoz Inc | ANDA | Current |
| 21695-415 | Perphenazine | Perphenazine | Rebel Distributors Corp | ANDA | Current |
| 53808-0760 | Perphenazine | PERPHENAZINE | State of Florida DOH Central Pharmacy | ANDA | Current |
| 67046-541 | Perphenazine | Perphenazine | Contract Pharmacy Services-PA | ANDA | Current |
| 70518-1158 | Perphenazine | Perphenazine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1158 | Perphenazine | Perphenazine | REMEDYREPACK INC. | ANDA | Current |
| 70518-3108 | Perphenazine | Perphenazine | REMEDYREPACK INC. | ANDA | Current |
| 70518-3108 | Perphenazine | Perphenazine | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 18528 | SUPPL | 2013-12-11 |