Drug Master Files for: varenicline
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varenicline Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 23033 | I | II | 7/31/2009 | ALP PHARM BEIJING CO LTD | VARENICLINE TARTRATE |
| 23441 | A | II | 1/12/2010 | MYLAN LABORATORIES LTD | VARENICLINE TARTRATE |
| 23708 | A | II | 4/12/2010 | TEVA PHARMACEUTICAL INDUSTRIES LTD | VARENICLINE TARTRATE (AS HPC SOLID SOLUTION) DRUG PRODUCT INTERMEDIATE |
| 23774 | A | II | 5/5/2010 | APOTEX PHARMACHEM INDIA PVT LTD | VARENICLINE TARTRATE |
| 23791 | A | II | 5/6/2010 | ACTAVIS GROUP PTC EHF | VARENICLINE TARTRATE MALTODEXTRIN PREMIX (1:10) [DRUG SUBSTANCE (NON-STERILE)] |
| 30182 | I | II | 12/22/2015 | VIWIT PHARMACEUTICAL CO LTD | VARENICLINE TARTRATE |
| 31513 | A | II | 4/13/2017 | LUPIN LTD | VARENICLINE TARTRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
