Drug Master Files for: dinoprost tromethamine

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dinoprost tromethamine Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10621	I	II	12/15/1993	CAYMAN PHARMA SRO	PROSTAGLANDIN E2 (DINOPROSTONE)
11274	A	II	12/27/1994	KYOWA PHARMA CHEMICAL CO LTD	DINOPROSTONE DRUG SUBSTANCE
11563	A	II	7/6/1995	CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD	DINOPROSTONE (PROSTAGLANDIN E2)
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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