Drug Master Files for: pentazocine hydrochloride

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pentazocine hydrochloride Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
12871	I	II	2/20/1998	MALLINCKRODT INC	PENTAZOCINE HYDROCHLORIDE USP
13983	A	II	2/9/1999	INDUSTRIALE CHIMICA SRL	PENTAZOCINE HYDROCHLORIDE
18345	A	II	2/11/2005	OLON SPA	PENTAZOCINE HYDROCHLORIDE
30214	A	II	4/20/2016	FIS FABBRICA ITALIANA SINTETICI SPA	PENTAZOCINE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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