Drug Master Files for: BENZONATATE

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BENZONATATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12327	A	II	1/21/1997	CATALENT PHARMA SOLUTIONS LLC	TESSALON 100 MG AND 200 MG SOFTGEL CAPSULES AND BENZONATATE 100 MG AND 200 MG SOFTGEL CAPSULES
12421	I	II	3/14/1997	NOVARTIS PHARMACEUTICALS CORP	TESSALON DRUG SUBSTANCE, (BENZONATATE, USP)
21703	A	II	6/16/2008	FORMOSA LABORATORIES INC	BENZONATATE USP
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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