Drug Master Files for: Dow Pharm

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Dow Pharm Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1256	I	II	12/5/1968	MERRELL DOW RESEARCH INSTITUTE DIV MERRELL DOW PHARMACEUTICAL INC	MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.
26891	A	II	4/17/2013	SHENZHEN TECHDOW PHARMACEUTICAL CO LTD	ENOXAPARIN SODIUM USP
32744	A	II	7/2/2018	SHENZHEN TECHDOW PHARMACEUTICAL CO LTD	ENOXAPARIN SODIUM USP
604	I		7/5/1963	MERRELL DOW PHARMS INC SUB MARION MERRELL DOW INC	MFG & PROCESS DATA; MONITORS RESPONS. FOR CLIN. & PHARMACOLOG. DATA
8358	I	I	12/22/1989	MERRELL DOW PHARMS CANADA INC	FACILITIES AND OPERATING PROCEDURES IN ONTARIO, CANADA
8982	I	I	2/18/1991	GRUPPO LEPETIT SPA SUB MERRELL DOW PHARMACEUTICALS INC	FACILITIES AND OPERATING PROCEDURES IN BRINDISI, ITALY
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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