Drug Master Files for: TADALAFIL
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TADALAFIL Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20640 | A | II | 6/15/2007 | MYLAN LABORATORIES LTD | TADALAFIL USP |
| 20884 | A | II | 9/26/2007 | TEVA PHARMACEUTICAL INDUSTRIES LTD | TADALAFIL |
| 20962 | A | II | 10/22/2007 | ORCHID PHARMA LTD | TADALAFIL |
| 21209 | I | II | 1/7/2008 | DR REDDYS LABORATORIES LTD | TADALAFIL |
| 22530 | A | II | 2/16/2009 | GLENMARK PHARMACEUTICALS LTD | TADALAFIL |
| 22707 | A | II | 3/31/2009 | ALEMBIC PHARMACEUTICALS LTD | TADALAFIL USP |
| 22771 | I | II | 5/13/2009 | SUN PHARMACEUTICAL INDUSTRIES LTD | TADALAFIL (NON STERILE BULK) DRUG SUBSTANCE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
