Application 009053
- Type
- NDA
- Sponsor
- STASON PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | PURINETHOL | MERCAPTOPURINE | TABLET;ORAL | 50MG | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60763-601 | PURINETHOL | Mercaptopurine | Stason Pharmaceuticals, Inc. | NDA | Current |
| 60763-601 | PURINETHOL | Mercaptopurine | Stason Pharmaceuticals, Inc. | NDA | Current |
| 69076-913 | Mercaptopurine | Mercaptopurine | Quinn Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
| 69076-913 | Mercaptopurine | Mercaptopurine | Quinn Pharmaceuticals, LLC | NDA AUTHORIZED GENERIC | Current |
| 69076-913 | Mercaptopurine | Mercaptopurine | Florida Pharmaceutical Product, LLC. | NDA AUTHORIZED GENERIC | Current |
| 69076-913 | Mercaptopurine | Mercaptopurine | Florida Pharmaceutical Product, LLC. | NDA AUTHORIZED GENERIC | Current |
| 69076-913 | Mercaptopurine | Mercaptopurine | Quinn Pharmaceuticals | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79052 | SUPPL | 2024-07-12 |
| 79036 | SUPPL | 2024-07-10 |
| 65795 | SUPPL | 2020-12-31 |
| 65779 | SUPPL | 2020-12-30 |
| 62800 | SUPPL | 2020-05-01 |
| 62761 | SUPPL | 2020-04-30 |
| 54333 | SUPPL | 2018-05-24 |
| 54317 | SUPPL | 2018-05-24 |
| 10716 | SUPPL | 2011-05-31 |
| 123 | SUPPL | 2011-05-31 |
| 10715 | SUPPL | 2004-07-21 |
| 32983 | SUPPL | 2003-01-10 |
| 174 | SUPPL | 2003-01-10 |
| 122 | SUPPL | 2002-09-06 |
| 121 | SUPPL | 2002-03-22 |