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Last Updated: September 27, 2023

Drug Master Files for: Ipr

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Ipr Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10095	A	III	2/12/1993	NIPRO PHARMAPACKAGING AMERICAS CORP	TUBING GLASS CONTAINERS
11001	A	III	7/26/1994	NIPRO PHARMAPACKAGING GERMANY GMBH	ARTICLES OF TUBULAR GLASS
11159	A	III	9/1/1994	NIPRO CORP	ELASTOMERIC CLOSURES
11998	A	III	5/24/1996	NIPRO CORP	VIALS / SYRINGE BARRELS
12149	I	II	10/7/1996	IPR PHARMACEUTICALS INC	ATENOLOL BULK DRUG
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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