Drug Master Files for: bicalutamide
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bicalutamide Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17008 | A | II | 12/5/2003 | TEVA PHARMACEUTICAL INDUSTRIES LTD | BICALUTAMIDE |
| 17878 | A | II | 12/3/2004 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | BICALUTAMIDE USP |
| 18141 | I | II | 3/3/2005 | CF PHARMA LTD | BICALUTAMIDE |
| 18374 | A | II | 5/26/2005 | USV PRIVATE LTD | BICALUTAMIDE |
| 18496 | A | II | 7/7/2005 | HETERO LABS LTD | BICALUTAMIDE (FORM-H1) |
| 18723 | A | II | 8/31/2005 | CIPLA LTD | BICALUTAMIDE USP |
| 18776 | I | II | 9/15/2005 | GEDEON RICHTER LTD | BICALUTAMIDE (MICRONIZED) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
