Drug Master Files for: almotriptan malate
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almotriptan malate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12475 | A | II | 4/17/1997 | RANKE QUIMICA SA | ALMOTRIPTAN, LAS 31416 D,L HYDROGEN MALATE |
| 18962 | A | II | 11/18/2005 | SMS PHARMACEUTICALS LTD | ALMOTRIPTAN MALATE |
| 20424 | A | II | 3/22/2007 | MYLAN LABORATORIES LTD | ALMOTRIPTAN MALATE USP |
| 25225 | I | II | 8/16/2011 | APOTEX PHARMACHEM INDIA PVT LTD | ALMOTRIPTAN MALATE |
| 25327 | A | II | 9/24/2011 | MSN LABORATORIES PRIVATE LTD | ALMOTRIPTAN MALATE USP [ROUTE CODE - AM] |
| 26177 | A | II | 7/13/2012 | ORCHID PHARMA LTD | ALMOTRIPTAN MALATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
