Application 075568
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZATHIOPRINE | AZATHIOPRINE | TABLET;ORAL | 50MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1005 | Azathioprine | azathioprine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1005 | Azathioprine | azathioprine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 43353-745 | Azathioprine | azathioprine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 51079-620 | Azathioprine | azathioprine | Mylan Institutional Inc. | ANDA | Current |
| 51079-620 | Azathioprine | azathioprine | Mylan Institutional Inc. | ANDA | Current |
| 51079-620 | Azathioprine | azathioprine | Mylan Institutional Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30939 | ORIG | 1999-12-13 |