Drug Master Files for: PROTRIPTYLINE HYDROCHLORIDE

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PROTRIPTYLINE HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
20365	A	II	3/22/2007	DIPHARMA FRANCIS SRL	PROTRIPTYLINE HYDROCHLORIDE
21234	I	II	1/15/2008	APICORE LLC	Protriptyline Hydrochloride
23673	A	II	4/2/2010	EMCURE PHARMACEUTICALS LTD	PROTRIPTYLINE HYDROCHLORIDE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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