Drug Master Files for: BETAXOLOL HYDROCHLORIDE

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BETAXOLOL HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10727	A	II	2/4/1994	LUSOCHIMICA SPA	BETAXOLOL HYDROCHLORIDE
12638	I	II	8/29/1997	ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV	BETAXOLOL HYDROCHLORIDE, USP
12680	I	II	10/2/1997	SIFAVITOR SRL	BETAXOLOL HYDROCHLORIDE
13279	I	II	10/19/1998	FINORGA SAS	LEVOBETAXOLOL 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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