Drug Master Files for: CHLOROTHIAZIDE

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CHLOROTHIAZIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
1059	I	II	5/10/1967	MICRO CHEMS LTD	HYDROCHLOROTHIAZIDE USP
15991	A	II	5/31/2002	DAIICHI SANKYO EUROPE GMBH	CS-866-HYDROCHLOROTHIAZIDE TABLETS (CS-866HCTZ)
16278	A	II	11/26/2002	UNICHEM LABORATORIES LTD	HYDROCHLOROTHIAZIDE USP
16707	A	II	7/7/2003	IPCA LABORATORIES LTD	HYDROCHLOROTHIAZIDE USP
16750	A	II	8/8/2003	CHANGZHOU PHARMACEUTICAL FACTORY	HYDROCHLOROTHIAZIDE
17599	A	II	8/12/2004	ZAKLADY FARMACEUTYCZNE POLPHARMA SA	HYDROCHLOROTHIAZIDE
17728	A	II	9/24/2004	AUROBINDO PHARMA LTD	HYDROCHLOROTHIAZIDE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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