Drug Master Files for: finasteride
✉ Email this page to a colleague
finasteride Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
15778 | A | II | 12/28/2001 | CIPLA LTD | FINASTERIDE USP |
16010 | A | II | 6/11/2002 | DR REDDYS LABORATORIES LTD | FINASTERIDE USP (FORM III) |
17575 | A | II | 7/26/2004 | GEDEON RICHTER PLC | FINASTERIDE USP |
17680 | A | II | 9/9/2004 | CIPLA LTD | FINASTERIDE USP |
18483 | A | II | 7/6/2005 | STERLING SPA | FINASTERIDE |
18551 | I | II | 7/28/2005 | CRYSTAL PHARMA SAU | FINASTERIDE |
19308 | A | II | 3/27/2006 | AUROBINDO PHARMA LTD | FINASTERIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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