Drug Master Files for: prasugrel hydrochloride
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prasugrel hydrochloride Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
25328 | A | II | 10/21/2011 | DR REDDYS LABORATORIES LTD | PRASUGREL HYDROCHLORIDE |
25651 | A | II | 12/30/2011 | MYLAN LABORATORIES LTD | PRASUGREL HYDROCHLORIDE |
25898 | A | II | 3/21/2012 | ALEMBIC PHARMACEUTICALS LTD | PRASUGREL HYDROCHLORIDE |
26769 | A | II | 12/28/2012 | HEC PHARM CO LTD | PRASUGREL HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE |
26879 | A | II | 4/12/2013 | LUPIN LTD | PRASUGREL HYDROCHLORIDE |
26925 | A | II | 3/25/2013 | GLENMARK PHARMACEUTICALS LTD | PRASUGREL HYDROCHLORIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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