Drug Master Files for: Wockhardt Ltd

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Wockhardt Ltd Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10943	I	II	6/20/1994	WOCKHARDT LTD	FACILITY AND OPERATING PROCEDURES IN CHIKALTHANA, AURANGABAD, MAHARASHTRA STATE, INDIA
11935	A	II	4/18/1996	WOCKHARDT LTD	DEXTROMETHORPHAN HYDROBROMIDE USP
12552	I	II	6/19/1997	WOCKHARDT LTD	RANITIDINE HYDROCHLORIDE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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