Drug Master Files for: diflunisal
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diflunisal Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
24762 | A | II | 3/15/2011 | AARTI INDUSTRIES LTD | DIFLUNISAL |
25743 | I | II | 6/18/2012 | JUHUA GROUP CORP PHARMACEUTICAL FACTORY | DIFLUNISAL USP |
28951 | A | II | 1/12/2015 | APICORE US LLC | DIFLUNISAL, USP |
3852 | I | II | 6/23/1980 | MERCK SHARP & DOHME RESEARCH LABS | DIFLUNISAL |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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