Drug Master Files for: sulfamethoxazole
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sulfamethoxazole Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10818 | I | II | 3/18/1994 | CHEMOX CHEMICAL INDUSTRIES LTD | SULFAMETHOXAZOLE |
13113 | I | II | 8/4/1998 | APTE AMALGAMATIONS LTD | SULFAMETHOXAZOLE |
13185 | A | II | 9/14/1998 | VIRCHOW LABORATORIES LTD | SULFAMETHOXAZOLE USP |
14982 | I | II | 7/25/2000 | TEVA GROUP | SULFAMETHOXAZOLE USP |
15414 | I | II | 5/4/2001 | VIBRANTIS SA DE CV | SULFAMETHOXAZOLE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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