Drug Master Files for: tazarotene
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tazarotene Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
16864 | I | II | 9/22/2003 | CARDINAL HEALTH PTS LLC | TAZAROTENE 1.5 MG AND 4.5 MG CAPSULES |
19089 | I | II | 1/3/2006 | BASF SE | TAZAROTENE |
20063 | I | II | 12/13/2006 | WATSON PHARMA PRIVATE LTD | TAZAROTENE |
21422 | A | II | 3/14/2008 | GLENMARK PHARMACEUTICALS LTD | TAZAROTENE |
24874 | A | II | 4/15/2011 | PIRAMAL HEALTHCARE CANADA LTD | TAZAROTENE |
25161 | A | II | 7/25/2011 | PCAS | TAZAROTENE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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