Drug Master Files for: azathioprine
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azathioprine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10119 | A | II | 2/19/1993 | FINE CHEMICALS CORP PTY LTD | AZATHIOPRINE |
| 12589 | I | II | 7/11/1997 | FERMION OY | AZATHIOPRINE |
| 16806 | I | II | 9/2/2003 | ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD | AZATHIOPRINE USP |
| 17598 | A | II | 8/12/2004 | RESOLUTION CHEMICALS LTD | AZATHIOPRINE USP |
| 18739 | I | II | 9/9/2005 | PROMETHEUS LABORATORIES INC | AZATHIOPRINE 50 MG TABLETS AND PLACEBO TABLETS |
| 19669 | I | II | 8/6/2006 | ZHEJIANG CHENG YI PHARMACEUTICAL CO LTD | AZATHIOPRINE USP, NON-STERILE A PHARMACEUTICAL INGREDIENT |
| 21674 | I | II | 6/4/2008 | RPG LIFE SCIENCES LTD | AZATHIOPRINE USP |
| >DMF No. | >Status | >Type | >Submission Date | >Holder | >Subject |
Drug Master File Glossary
STATUS OF DMFS
- A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
- I = Inactive
- N = Not an assigned number
- P = DMF Pending Filing Review
TYPES OF DMFs
- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III Packaging Material
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V FDA Accepted Reference Information
