Drug Master Files for: MYCOPHENOLATE MOFETIL HYDROCHLORIDE
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MYCOPHENOLATE MOFETIL HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16406 | A | II | 1/20/2003 | BIOCON LTD | MYCOPHENOLATE MOFETIL |
| 18494 | A | II | 7/11/2005 | CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD | MYCOPHENOLATE MOFETIL USP |
| 18936 | I | II | 11/7/2005 | LEK PHARMACEUTICALS DD | MYCOPHENOLATE MOFETIL |
| 18989 | I | II | 11/28/2005 | IVAX PHARMACEUTICALS SRO | MYCOPHENOLATE MOFETIL USP |
| 19231 | A | II | 3/7/2006 | CONCORD BIOTECH LTD | MYCOPHENOLATE MOFETIL USP |
| 20072 | A | II | 12/20/2006 | TEVA PHARMACEUTICAL INDUSTRIES LTD | MYCOPHENOLATE MOFETIL DRUG SUBSTANCE |
| 20655 | A | II | 7/2/2007 | SHANDONG NEW TIME PHARMACEUTICAL CO LTD | MYCOPHENOLATE MOFETIL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
