Drug Master Files for: TAPENTADOL HYDROCHLORIDE

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TAPENTADOL HYDROCHLORIDE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
21084	A	II	1/23/2008	NORAMCO INC	TAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE
26490	A	II	9/27/2012	EUTICALS INC	TAPENTADOL HYDROCHLORIDE DRUG SUBSTANCE
26519	A	II	10/23/2012	ALKEM LABORATORIES LTD	TAPENTADOL HYDROCHLORIDE
28541	A	II	9/25/2014	AMPAC FINE CHEMICALS LLC	TAPENTADOL HCI
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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