Drug Master Files for: MEFENAMIC ACID
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MEFENAMIC ACID Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
16491 | A | II | 3/20/2003 | WANBURY LTD | MEFENAMIC ACID USP |
18904 | A | II | 9/21/2005 | CHENG FONG CHEMICAL CO LTD | MEFENAMIC ACID |
19195 | A | II | 2/23/2006 | SOLARA A PHARMA SCIENCES LTD | MEFENAMIC ACID, USP |
20374 | A | II | 3/21/2007 | TAI HENG INDUSTRY CO LTD | MEFENAMIC ACID USP |
20778 | I | II | 8/17/2007 | TONIRA PHARMA LTD | MEFENAMIC ACID |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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