Drug Master Files for: ASCORBIC ACID

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ASCORBIC ACID Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
23162	A	II	10/7/2009	CSPC WEISHENG PHARMACEUTICAL SHIJIAZHUANG CO LTD	ASCORBIC ACID (VITAMIN C)
23235	A	II	10/30/2009	MCGUFF PHARMACEUTICALS INC	ASCOR L 500? (ASCORBIC ACID INJECTION USP)
26596	A	II	11/5/2012	AMOLI ORGANICS PVT LTD	ASCORBIC ACID 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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