Drug Master Files for: LOXAPINE HYDROCHLORIDE

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LOXAPINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13135	I	II	8/14/1998	INSTITUTE DRUG TECHNOLOGY AUSTRALIA LTD	LOXAPINE BASE
23144	A	II	9/30/2009	MEDICHEM SA	LOXAPINE BASE
29977	A	II	11/6/2015	CENTAUR PHARMACEUTICALS PRIVATE LTD	LOXAPINE SUCCINATE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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