Drug Master Files for: valacyclovir hydrochloride
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valacyclovir hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16300 | A | II | 12/11/2002 | SUN PHARMACEUTICAL INDUSTRIES LTD | VALACYCLOVIR HYDROCHLORIDE USP (HYDROUS) |
| 17223 | A | II | 3/10/2003 | CIPLA LTD | VALACYCLOVIR HYDROCHLORIDE DIHYDRATE USP |
| 17794 | A | II | 10/25/2004 | TEVA PHARMACEUTICAL INDUSTRIES LTD | VALACYCLOVIR HYDROCHLORIDE |
| 17943 | A | II | 12/29/2004 | MYLAN LABORATORIES LTD | VALACYCLOVIR HYDROCHLORIDE USP |
| 18940 | I | II | 10/25/2005 | OLON SPA | VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE |
| 20278 | I | II | 2/9/2007 | EOS ECZACIBASI OZGUN KIMYASAL URUNLER SANAYI VE TICARET AS | VALACYCLOVIR HCI MONOHYDRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
