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Application 213479
- Type
- ANDA
- Sponsor
- NOVITIUM PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | TABLET;ORAL | 2MG | No | No |
| 002 | LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | TABLET;ORAL | 3MG | No | No |
| 003 | LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | TABLET;ORAL | 1MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0527-3236 | Levorphanol Tartrate | Levorphanol Tartrate | Lannett Company, Inc. | ANDA | Current |
| 0527-3236 | Levorphanol Tartrate | Levorphanol Tartrate | Lannett Company, Inc. | ANDA | Current |
| 0527-3236 | Levorphanol Tartrate | Levorphanol Tartrate | Lannett Company, Inc. | ANDA | Current |
| 0527-3237 | Levorphanol Tartrate | Levorphanol Tartrate | Lannett Company, Inc. | ANDA | Current |
| 0527-3237 | Levorphanol Tartrate | Levorphanol Tartrate | Lannett Company, Inc. | ANDA | Current |
| 63629-2093 | Levorphanol Tartrate | Levorphanol Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 63629-2093 | Levorphanol Tartrate | Levorphanol Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 63629-2093 | Levorphanol Tartrate | Levorphanol Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 70954-236 | Levorphanol Tartrate | Levorphanol Tartrate | Novitium Pharma LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76461 | ORIG | 2023-11-07 |