Drug Master Files for: nepafenac

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nepafenac Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17812	A	II	11/3/2004	CARBOGEN AMCIS AG	NEPAFENAC
22636	A	II	3/19/2009	CEDARBURG PHARMACEUTICALS INC	NEPAFENAC DRUG SUBSTANCE
23032	A	II	7/30/2009	ALP PHARM BEIJING CO LTD	NEPAFENAC
25528	I	II	12/17/2014	CHEMWERTH INC	NEPAFENAC
28205	I	II	12/29/2015	CHEMWERTH INC	NEPAFENAC STERILE BULK DRUG SUBSTANCE
28432	A	II	7/22/2014	MEDICHEM SA	NEPAFENAC
30593	A	II	6/21/2016	MYLAN LABORATORIES LTD	NEPAFENAC
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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