Drug Master Files for: TINIDAZOLE

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TINIDAZOLE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10350	I	II	6/23/1993	ZAKLADY FARMACEUTYCZNE POLPHARMA SA	TINIDAZOLE
1704	I	II	4/20/1971	PFIZER INC	TINIDAZOLE BULK
18824	A	II	9/26/2005	ZHEJIANG SUPOR PHARMACEUTICALS CO LTD	TINIDAZOLE (NON-STERILE DRUG SUBSTANCE)
6226	I	II	9/6/1985	PFIZER LABORATORIES DIV PFIZER INC	TINIDAZOLE
6275	I	II	4/21/1986	FARCHEMIA SRL	TINIDAZOLE USP XXI
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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