Drug Master Files for: TRIMETHOPRIM
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TRIMETHOPRIM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11934 | I | II | 4/16/1996 | STANDARD ORGANICS LTD | TRIMETHOPRIM USP (NON-STERILE BULK) |
| 12734 | I | II | 11/7/1997 | WYCKOFF CHEMICAL CO INC | TRIMETHOPRIM |
| 12816 | I | II | 1/7/1998 | HALCYON LABS PRIVATE LTD | TRIMETHOPRIM USP |
| 13144 | A | II | 8/18/1998 | SHANDONG XINHUA PHARMACEUTICAL CO LTD | TRIMETHOPRIM USP |
| 15506 | A | II | 6/28/2001 | INVENTAA INDUSTRIES PRIVATE LTD | TRIMETHOPRIM USP |
| 15510 | I | II | 6/29/2001 | SIFAVITOR SRL | TRIMETHOPRIM |
| 15984 | I | II | 5/23/2002 | ALPHA DRUG INDIA LTD | TRIMETHOPRIM |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
