Drug Master Files for: BIVALIRUDIN
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BIVALIRUDIN Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
12797 | A | II | 12/22/1997 | POLYPEPTIDE SA | HIRULOG (BIVALIRUDIN)- A PHARMACEUTICAL INGREDIENT |
20853 | A | II | 9/14/2007 | AMBIOPHARM INC | BIVALIRUDIN, NON-STERILE BULK DRUG SUBSTANCE |
20863 | A | II | 9/18/2007 | TEVA PHARMACEUTICAL INDUSTRIES LTD | BIVALIRUDIN |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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