Drug Master Files for: eptifibatide
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eptifibatide Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
14267 | A | II | 7/6/1999 | ASPEN OSS BV | EPTIFIBATIDE |
18565 | A | II | 8/1/2005 | POLYPEPTIDE SA | EPTIFIBATIDE DRUG SUBSTANCE |
21913 | A | II | 8/28/2008 | TEVA PHARMACEUTICAL INDUSTRIES LTD | EPTIFIBATIDE |
23786 | A | II | 4/30/2010 | ALP PHARM BEIJING CO LTD | EPTIFIBATIDE |
24864 | A | II | 4/18/2011 | AMBIOPHARM INC | EPTIFIBATIDE (NON-STERILE, BULK DRUG SUBSTANCE) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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