Drug Master Files for: clomiphene citrate
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clomiphene citrate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14728 | I | II | 2/21/2000 | PCAS | CLOMIPHENE CITRATE |
| 28727 | A | II | 10/2/2014 | BIOVECTRA INC | ENCLOMIPHENE CITRATE |
| 28947 | A | II | 1/20/2015 | PCAS | CLOMIPHENE CITRATE |
| 29195 | A | II | 4/16/2015 | PCAS | ENCLOMIPHENE CITRATE |
| 31739 | A | II | 5/25/2017 | FIS FABBRICA ITALIANA SINTETICI SPA | ENCLOMIPHENE CITRATE |
| 32838 | A | II | 6/4/2018 | PCAS | ZUCLOMIPHENE CITRATE |
| 3957 | A | II | 10/6/1980 | TEVA PHARMACEUTICAL INDUSTRIES LTD | CLOMIPHENE CITRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
