Drug Master Files for: PYRAZINAMIDE
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PYRAZINAMIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14623 | I | II | 12/16/1999 | SANOFI AVENTIS | PYRAZINAMIDE |
15325 | A | II | 2/28/2001 | DELMAR CHEMICALS INC | PYRAZINAMIDE |
15553 | A | II | 7/31/2001 | CALYX CHEMICALS AND PHARMACEUTICALS LTD | PYRAZINAMIDE USP |
1597 | I | 10/26/1970 | H REISMAN CORP | PYRAZINAMIDE | |
30448 | A | II | 5/25/2016 | MACLEODS PHARMACEUTICALS LTD | PYRAZINAMIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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