Drug Master Files for: FLUOXETINE HYDROCHLORIDE

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FLUOXETINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10837	A	II	3/28/1994	ERREGIERRE SPA	FLUOXETINE HYDROCHLORIDE USP-EP
11315	A	II	1/26/1995	FERMION OY	FLUOXETINE HYDROCHLORIDE USP
11699	I	II	10/4/1995	SIMS SRL	FLUOXETINE HCL
11992	I	II	6/7/1996	NATCO PHARMA LTD	FLUOXETINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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