Drug Master Files for: EXENATIDE
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EXENATIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17114 | A | II | 1/19/2004 | SPECGX LLC | EXENATIDE |
| 17227 | A | II | 3/5/2004 | BACHEM AMERICAS INC | EXENATIDE (BULK) |
| 19646 | A | II | 7/31/2006 | POLYPEPTIDE LABORATORIES SWEDEN AB | EXENATIDE DRUG SUBSTANCE |
| 27123 | A | II | 7/7/2013 | TEVA PHARMACEUTICAL INDUSTRIES LTD | EXENATIDE |
| 27714 | A | II | 1/13/2014 | POLYPEPTIDE LABORATORIES SWEDEN AB | EXENDIN-4 ACETATE (EXENATIDE) |
| 29863 | A | II | 12/31/2015 | SUN PHARMACEUTICAL INDUSTRIES LTD | EXENATIDE |
| 30924 | A | II | 9/28/2016 | POLYPEPTIDE LABORATORIES SWEDEN AB | EXENATIDE USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
