Application 075759
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | SPRAY, METERED;NASAL | 1MG/SPRAY | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-9639 | Butorphanol Tartrate | butorphanol tartrate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9639 | Butorphanol Tartrate | butorphanol tartrate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9639 | Butorphanol Tartrate | butorphanol tartrate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9639 | Butorphanol Tartrate | butorphanol tartrate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-9639 | Butorphanol Tartrate | butorphanol tartrate | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76122 | ORIG | 2023-11-03 |