Drug Master Files for: METHYLDOPA

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METHYLDOPA Drug Master Files

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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
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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