Drug Master Files for: albendazole
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albendazole Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12308 | I | II | 1/10/1997 | CHANGZOU SYNTHETIC MATERIAL PLANT | ALBENDAZOLE |
| 17754 | A | II | 11/8/2004 | UNIMARK REMEDIES LTD | ALBENDAZOLE USP |
| 25914 | A | II | 3/27/2012 | UQUIFA MEXICO SA DE CV | ALBENDAZOLE |
| 28558 | A | II | 8/13/2014 | SOLARA A PHARMA SCIENCES LTD | ALBENDAZOLE |
| 29493 | A | II | 6/30/2015 | CIPLA LTD | ALBENDAZOLE USP |
| 30967 | A | II | 10/28/2016 | CIPLA LTD | ALBENDAZOLE (B) USP |
| 31341 | A | II | 1/31/2017 | MSN LIFE SCIENCES PRIVATE LTD | ALBENDAZOLE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
