Drug Master Files for: LABETALOL HYDROCHLORIDE

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LABETALOL HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10901	I	II	5/18/1994	TEVA PHARMACEUTICAL INDUSTRIES LTD	LABETALOL HYDROCHLORIDE
10918	A	II	6/8/1994	PROCOS SPA	LABETALOL HCl
11779	A	II	12/22/1995	OLON SPA	LABETALOL HYDROCHLORIDE
12758	A	II	11/24/1997	CAMBREX PROFARMACO MILANO SRL	LABETALOL HYDROCHLORIDE
14702	A	II	2/4/2000	COSMA SPA	LABETALOL HYDROCHLORIDE
16314	A	II	12/17/2002	TEVA PHARMACEUTICAL INDUSTRIES LTD	LABETALOL 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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