Drug Master Files for: SOTALOL HYDROCHLORIDE

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SOTALOL HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11887	I	II	3/6/1996	IROTEC LABORATORIES	SOTALOL HYDROCHLORIDE
12273	A	II	12/17/1996	CAMBREX PROFARMACO MILANO SRL	SOTALOL HCL
13083	I	II	7/21/1998	ERREGIERRE SPA	SOTALOL 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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