Drug Master Files for: famciclovir
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famciclovir Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17908 | A | II | 12/16/2004 | TEVA PHARMACEUTICAL INDUSTRIES LTD | FAMCICLOVIR |
| 18690 | I | II | 8/18/2005 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | FAMCICLOVIR (NON-STERILE A PHARMACEUTICAL INGREDIENT) |
| 19181 | A | II | 3/9/2006 | CIPLA LTD | FAMCICLOVIR USP |
| 19692 | A | II | 8/17/2006 | CHONGQING SHENGHUAXI PHARMACEUTICAL CO LTD | FAMCICLOVIR |
| 22204 | A | II | 11/19/2008 | AUROBINDO PHARMA LTD | FAMCICLOVIR USP |
| 22391 | A | II | 1/9/2009 | MACLEODS PHARMACEUTICALS LTD | FAMCICLOVIR |
| 22713 | A | II | 4/9/2009 | SIGNA SA DE CV | FAMCICLOVIR 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
