Application 064071
- Type
- ANDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | TABLET;ORAL | EQ 250MG BASE | No | No |
| 002 | PENICILLIN V POTASSIUM | PENICILLIN V POTASSIUM | TABLET;ORAL | EQ 500MG BASE | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-1205 | Penicillin V Potasium | Penicillin V Potasium | Sandoz Inc | ANDA | Current |
| 0781-1205 | Penicillin V Potasium | Penicillin V Potasium | Sandoz Inc | ANDA | Current |
| 0781-1205 | Penicillin V Potasium | Penicillin V Potasium | Sandoz Inc | ANDA | Current |
| 0781-1655 | Penicillin V Potasium | Penicillin V Potasium | Sandoz Inc | ANDA | Current |
| 0781-1655 | Penicillin V Potasium | Penicillin V Potasium | Sandoz Inc | ANDA | Current |
| 0781-1655 | Penicillin V Potasium | Penicillin V Potasium | Sandoz Inc | ANDA | Current |
| 10544-975 | Penicillin V Potasium | Penicillin V Potasium | Blenheim Pharmacal, Inc. | ANDA | Current |
| 53217-290 | Penicillin V Potasium | Penicillin V Potasium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55700-404 | Penicillin V Potasium | Penicillin V Potasium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 67296-0044 | Penicillin V Potasium | Penicillin V Potasium | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0044 | Penicillin V Potasium | Penicillin V Potasium | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0044 | Penicillin V Potasium | Penicillin V Potasium | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1164 | Penicillin V Potasium | Penicillin V Potasium | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1164 | Penicillin V Potasium | Penicillin V Potasium | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1164 | Penicillin V Potasium | Penicillin V Potasium | RedPharm Drug, Inc. | ANDA | Current |
| 70518-2192 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2192 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2192 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2441 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2441 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2482 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2482 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2482 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2529 | Penicillin V Potasium | Penicillin V Potasium | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 18319 | SUPPL | 2014-02-06 |