Drug Master Files for: ganciclovir
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ganciclovir Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
15567 | A | II | 7/31/2001 | EXCELLA GMBH AND CO KG | GANCICLOVIR |
16043 | I | II | 7/8/2002 | RANBAXY LABORATORIES LTD | GANCICLOVIR |
16992 | A | II | 11/17/2003 | EXCELLA GMBH AND CO KG | GANCICLOVIR SODIUM |
19049 | I | II | 12/21/2005 | SUN PHARMACEUTICAL INDUSTRIES LTD | GANCICLOVIR (INTERMEDIATE DRUG SUBSTANCE) |
19060 | I | II | 12/21/2005 | SUN PHARMACEUTICAL INDUSTRIES LTD | VALGANCICLOVIR HYDROCHLORIDE (NON-STERILE BULK) |
23044 | A | II | 8/4/2009 | OLON SPA | VALGANCICLOVIR HYDROCHLORIDE AMORPHOUS |
23322 | A | II | 11/30/2009 | MYLAN LABORATORIES LTD | VALGANCICLOVIR HYDROCHLORIDE USP (CRYSTALLINE) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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