Drug Master Files for: bexarotene
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bexarotene Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 23545 | I | II | 3/16/2010 | USV LTD | BEXAROTENE |
| 23631 | A | II | 4/26/2010 | APICORE US LLC | BEXAROTENE |
| 25542 | A | II | 11/29/2011 | AVANTHERA SA | BEXAROTENE |
| 28944 | A | II | 12/22/2014 | HETERO LABS LTD | BEXAROTENE |
| 30077 | A | II | 1/13/2016 | MSN LABORATORIES PRIVATE LTD | BEXAROTENE [ROUTE CODE BX] |
| 31580 | A | II | 4/5/2017 | TIANJIN WEIJIE PHARMACEUTICAL CO LTD | BEXAROTENE |
| 31979 | A | II | 10/3/2017 | EMCURE PHARMACEUTICALS LTD | BEXAROTENE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
