Drug Master Files for: methyldopa
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methyldopa Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
1753 | I | II | 6/25/1971 | MONSANTO CO | L-3-O-METHYLDOPA |
17699 | I | II | 9/19/2004 | DIVIS LABORATORIES LTD | METHYLDOPA USP |
20565 | A | II | 5/15/2007 | ZHEJIANG CHIRAL MEDICINE CHEMICALS CO LTD | METHYLDOPA |
22425 | A | II | 12/12/2008 | ZHEJIANG WILD WIND PHARMACEUTICAL CO LTD | METHYLDOPA (NON-STERILE, BULK FORM) |
24152 | A | II | 8/1/2010 | SERATEC SAS | METHYLDOPATE HYDROCHLORIDE USP |
26726 | A | II | 1/24/2013 | TEVA PHARMACEUTICAL INDUSTRIES LTD | METHYLDOPA |
2696 | I | II | 6/2/1976 | ANTIBIOTICOS SPA | METHYLDOPA 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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