Drug Master Files for: saxagliptin hydrochloride
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saxagliptin hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 26924 | A | II | 4/29/2013 | MEDICHEM MANUFACTURING MALTA LTD | SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE |
| 26977 | A | II | 5/3/2013 | GLENMARK PHARMACEUTICALS LTD | SAXAGLIPTIN MONOHYDRATE |
| 27083 | A | II | 7/17/2013 | WOCKHARDT BIO AG | SAXAGLIPTIN HYDROCHLORIDE |
| 27111 | A | II | 5/9/2013 | AUROBINDO PHARMA LTD | SAXAGLIPTIN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE) |
| 27146 | A | II | 6/26/2013 | MYLAN LABORATORIES LTD | SAXAGLIPTIN HYDROCHLORIDE |
| 27174 | A | II | 6/27/2013 | TEVA PHARMACEUTICAL INDUSTRIES LTD | SAXAGLIPTIN MONOHYDRATE |
| 27189 | A | II | 6/14/2013 | RAKS PHARMA PVT LTD | SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
