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Last Updated: April 19, 2024

Drug Master Files for: NIFEDIPINE

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NIFEDIPINE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10280	I	II	6/7/1993	UNIQUE CHEMICALS	NIFEDIPINE
11948	A	II	4/24/1996	EVONIK NUTRITION AND CARE GMBH	NIFEDIPINE
13115	I	II	8/7/1998	CHINA CHEMICAL SYNTHESIS INDUSTRIAL CO LTD	NIFEDIPINE USP, (BULK A PHARMACEUTICAL INGREDIENT), MANFACTURED IN TAIWAN, THE REPUBLIC OF CHINA
15293	A	II	2/15/2001	CATALENT PHARMA SOLUTIONS LLC	NIFEDIPINE (10MG AND 20MG) SOFTGEL CAPSULE
16730	A	II	7/29/2003	UNIQUE CHEMICALS (A DIV OF J B CHEMICALS AND PHARMACEUTICALS LTD)	NIFEDIPINE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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