Application 075499
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | SPRAY, METERED;NASAL | 1MG/SPRAY | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60505-0813 | Butorphanol Tartrate | Butorphanol Tartrate | Apotex Corp. | ANDA | Current |
| 60505-0813 | Butorphanol Tartrate | Butorphanol Tartrate | Apotex Corp. | ANDA | Current |
| 60505-0813 | Butorphanol Tartrate | Butorphanol Tartrate | Apotex Corp. | ANDA | Current |
| 60505-0813 | Butorphanol Tartrate | Butorphanol Tartrate | Apotex Corp. | ANDA | Current |
| 60505-0813 | Butorphanol Tartrate | Butorphanol Tartrate | Apotex Corp. | ANDA | Current |
| 60505-0813 | Butorphanol Tartrate | Butorphanol Tartrate | Apotex Corp. | ANDA | Current |
| 60505-0813 | Butorphanol Tartrate | Butorphanol Tartrate | Apotex Corp. | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 76303 | ORIG | 2023-11-03 |
| 22478 | ORIG | 2007-07-27 |