Drug Master Files for: DABIGATRAN ETEXILATE MESYLATE
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DABIGATRAN ETEXILATE MESYLATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 27037 | A | II | 6/29/2013 | MSN LABORATORIES PRIVATE LTD | DABIGATRAN ETEXILATE MESYLATE [ROUTE CODE - DE] |
| 27620 | A | II | 10/1/2013 | ZAKLADY FARMACEUTYCZNE POLPHARMA SA | DABIGATRAN ETEXILATE METHANESULFONATE |
| 27781 | A | II | 12/31/2013 | ALEMBIC PHARMACEUTICALS LTD | DABIGATRAN ETEXILATE MESYLATE |
| 27892 | A | II | 3/25/2014 | GLENMARK PHARMACEUTICALS LTD | DABIGATRAN ETEXILATE MESYLATE |
| 27960 | A | II | 4/4/2014 | DR REDDYS LABORATORIES LTD | DABIGATRAN ETEXILATE MESYLATE |
| 28029 | A | II | 3/28/2014 | APOTEX PHARMACHEM INDIA PVT LTD | DABIGATRAN ETEXILATE MESYLATE |
| 28039 | A | II | 4/11/2014 | LUPIN LTD | DABIGATRAN ETEXILATE MESYLATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
