Application 074278
- Type
- ANDA
- Sponsor
- SENTYNL THERAPS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | TABLET;ORAL | 2MG | No | Yes |
| 002 | LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | TABLET;ORAL | 1MG | No | No |
| 003 | LEVORPHANOL TARTRATE | LEVORPHANOL TARTRATE | TABLET;ORAL | 3MG | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42358-101 | Levorphanol Tartrate | Levorphanol Tartrate | Sentynl Therapeutics, Inc. | ANDA | Current |
| 42358-102 | Levorphanol Tartrate | Levorphanol Tartrate | Sentynl Therapeutics, Inc. | ANDA | Current |
| 42358-102 | Levorphanol Tartrate | Levorphanol Tartrate | Sentynl Therapeutics, Inc. | ANDA | Current |
| 42358-102 | Levorphanol Tartrate | Levorphanol Tartrate | Sentynl Therapeutics, Inc. | ANDA | Current |
| 42358-102 | Levorphanol Tartrate | Levorphanol Tartrate | Sentynl Therapeutics, Inc. | ANDA | Current |
| 42358-102 | Levorphanol Tartrate | Levorphanol Tartrate | Sentynl Therapeutics, Inc. | ANDA | Current |
| 42358-102 | Levorphanol Tartrate | Levorphanol Tartrate | Sentynl Therapeutics, Inc. | ANDA | Current |
| 42358-103 | Levorphanol Tartrate | Levorphanol Tartrate | Sentynl Therapeutics, Inc. | ANDA | Current |
| 42358-103 | Levorphanol Tartrate | Levorphanol Tartrate | Sentynl Therapeutics, Inc. | ANDA | Current |
| 42358-103 | Levorphanol Tartrate | Levorphanol Tartrate | Sentynl Therapeutics, Inc. | ANDA | Current |
| 42358-103 | Levorphanol Tartrate | Levorphanol Tartrate | Sentynl Therapeutics, Inc. | ANDA | Current |
| 42358-103 | Levorphanol Tartrate | Levorphanol Tartrate | Sentynl Therapeutics, Inc. | ANDA | Current |
| 42358-103 | Levorphanol Tartrate | Levorphanol Tartrate | Sentynl Therapeutics, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76169 | ORIG | 2023-11-03 |
| 54904 | SUPPL | 2018-07-16 |
| 22326 | ORIG | 2005-07-22 |
| 8411 | ORIG | 2000-03-31 |