Application 016324
- Type
- NDA
- Sponsor
- SEBELA IRELAND LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IMURAN | AZATHIOPRINE | TABLET;ORAL | 50MG | Yes | Yes |
| 002 | IMURAN | AZATHIOPRINE | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 54766-590 | IMURAN | azathioprine | Sebela Pharmaceuticals Inc. | NDA | Current |
| 65483-590 | IMURAN | azathioprine | Prometheus Laboratories Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79050 | SUPPL | 2024-07-11 |
| 79034 | SUPPL | 2024-07-10 |
| 57004 | SUPPL | 2018-12-21 |
| 56943 | SUPPL | 2018-12-21 |
| 50509 | SUPPL | 2017-11-27 |
| 12990 | SUPPL | 2014-02-11 |
| 33164 | SUPPL | 2014-02-07 |
| 12989 | SUPPL | 2011-05-26 |
| 441 | SUPPL | 2011-05-26 |
| 33163 | SUPPL | 2011-05-25 |
| 10886 | SUPPL | 2011-05-25 |
| 12988 | SUPPL | 2008-07-14 |
| 10885 | SUPPL | 2008-07-10 |
| 33162 | SUPPL | 2005-07-29 |
| 12987 | SUPPL | 2005-07-29 |
| 440 | SUPPL | 2004-06-07 |