Drug Master Files for: entacapone
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entacapone Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12444 | A | II | 3/26/1997 | FERMION OY | ENTACAPONE |
| 19092 | A | II | 1/6/2006 | SUVEN LIFE SCIENCES LTD | ENTACAPONE |
| 19385 | A | II | 3/1/2006 | WOCKHARDT LTD | ENTACAPONE USP |
| 20326 | A | II | 2/28/2007 | SUN PHARMACEUTICAL INDUSTRIES LTD | ENTACAPONE |
| 21526 | A | II | 4/11/2008 | NEULAND LABORATORIES LTD | ENTACAPONE USP (FORM-A) |
| 22133 | I | II | 11/21/2008 | USV LTD | ENTACAPONE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
