Drug Master Files for: trientine hydrochloride

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trientine hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12659	A	II	9/18/1997	AMRI RENSSELAER INC	TRIENTINE HCL USP
29019	A	II	9/25/2015	CHEMWERTH INC	TRIENTINE HYDROCHLORIDE USP
29085	A	II	8/27/2015	TEVA PHARMACEUTICAL INDUSTRIES LTD	TRIENTINE HYDROCHLORIDE USP
29527	A	II	9/3/2015	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	TRIENTINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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