Drug Master Files for: VARENICLINE TARTRATE
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VARENICLINE TARTRATE 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 |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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