Drug Master Files for: ESMOLOL HYDROCHLORIDE

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ESMOLOL HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
15743	I	II	11/30/2001	BOEHRINGER INGELHEIM LTD	ESMOLOL HCL
16053	A	II	6/27/2002	CHEMWERTH INC	ESMOLOL HCL
16863	A	II	9/24/2003	TARO PHARMACEUTICAL INDUSTRIES LTD	ESMOLOL 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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