Drug Master Files for: triple
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triple Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14580 | I | IV | 11/15/1999 | FONA INTERNATIONAL INC | 807.120 N-C TRIPLEBERRY FLAVOR ARTIFICIAL |
29307 | A | III | 4/18/2015 | YEN FLEXI PACK | TRIPLE LAMINATED BAGS FOR PHARMACEUTICAL USE |
32045 | A | III | 9/1/2017 | FLEXIFOIL PACKAGING PVT LTD | PLAIN, PRINTED, COATED, LAMINATED ALUMINIUM FOIL, COLD FORMING FOILS, CR FOILS, TROPICAL BLISTERS, TRIPLE LAMINATED POUCHES, BAGS, MULTILAYER LAMINATED FILMS & |
32497 | A | III | 2/8/2018 | UNIWORTH ENTERPRISES LLP | TRIPLEX (PVC/PE/PVDC) FILMS |
6411 | I | II | 6/12/1986 | MERCK KGAA | TITRIPLEX VS, DIETHYLENETRIAMINEPENTAACETIC 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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