Drug Master Files for: SITAGLIPTIN
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SITAGLIPTIN Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 23864 | A | II | 6/3/2010 | MSN PHARMACHEM PRIVATE LTD | SITAGLIPTIN PHOSPHATE MONOHYDRATE USP (ROUTE CODE SG) |
| 24067 | A | II | 8/16/2010 | MYLAN LABORATORIES LTD | SITAGLIPTIN PHOSPHATE |
| 24148 | A | II | 9/9/2010 | TEVA PHARMACEUTICAL INDUSTRIES LTD | SITAGLIPTIN PHOSPHATE |
| 24199 | A | II | 10/9/2010 | SUN PHARMACEUTICAL INDUSTRIES LTD | SITAGLIPTIN PHOSPHATE USP |
| 24266 | A | II | 10/8/2010 | APOTEX PHARMACHEM INC | SITAGLIPTIN PHOSPHATE MONOHYDRATE USP |
| 25773 | A | II | 3/29/2012 | GLENMARK PHARMACEUTICALS LTD | SITAGLIPTIN PHOSPHATE |
| 25867 | A | II | 3/2/2012 | TEVA PHARMACEUTICAL INDUSTRIES LTD | SITAGLIPTIN PHOSPHATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
