Drug Master Files for: acetazolamide
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acetazolamide Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10383 | A | II | 7/30/1993 | ZAKLADY FARMACEUTYCZNE POLPHARMA SA | ACETAZOLAMIDE |
12997 | A | II | 5/21/1998 | IDT AUSTRALIA LTD | ACETAZOLAMIDE USP |
19763 | A | II | 8/24/2006 | NAKODA CHEMICALS LTD | ACETAZOLAMIDE |
20299 | A | II | 2/23/2007 | EMCURE PHARMACEUTICALS LTD | ACETAZOLAMIDE USP |
22420 | A | II | 1/22/2009 | REGIS TECHNOLOGIES INC | ACETAZOLAMIDE, USP |
23014 | A | II | 7/31/2009 | CTX LIFE SCIENCES PVT LTD | ACETAZOLAMIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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