Drug Master Files for: ENTECAVIR
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ENTECAVIR Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 23663 | A | II | 5/21/2010 | CIPLA LTD | ENTECAVIR MONOHYDRATE USP |
| 24305 | I | II | 10/19/2010 | APOTEX PHARMACHEM INDIA PVT LTD | ENTECAVIR USP |
| 24601 | A | II | 1/28/2011 | CHONGQING CARELIFE PHARMACEUTICAL CO LTD | ENTECAVIR HYDRATE USP, NON-STERILE BULK DRUG SUBSTANCE |
| 25200 | A | II | 8/5/2011 | ZHEJIANG AUSUN PHARMACEUTICAL CO LTD | ENTECAVIR MONOHYDRATE BULK DRUG SUBSTANCE |
| 25549 | A | II | 11/30/2011 | SCINOPHARM TAIWAN LTD | ENTECAVIR MONOHYDRATE USP |
| 26307 | A | II | 8/14/2012 | HETERO DRUGS LTD | ENTECAVIR MONOHYDRATE |
| 27066 | I | II | 4/5/2013 | KYONGBO PHARMACEUTICAL CO LTD | ENTECAVIR |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
