Drug Master Files for: isoniazid

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isoniazid Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14662	I	II	1/10/2000	BEIJING SECOND PHARMACEUTICAL FACTORY	ISONIAZID USP23
16235	A	II	11/5/2002	YANGZHOU PHARMACEUTICAL CO LTD	ISONIAZID
21322	A	II	2/7/2008	CALYX CHEMICALS AND PHARMACEUTICALS LTD	ISONIAZID
4772	A	II	12/7/1982	YUKI GOSEI KOGYO CO LTD	ISONIAZID BULK FORM
5890	I	II	6/21/1985	BAYER CORP	ISONIAZID (NEOTEBEN)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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