Drug Master Files for: clomiphene citrate

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clomiphene citrate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
14728	I	II	2/21/2000	PCAS	CLOMIPHENE CITRATE
28727	A	II	10/2/2014	BIOVECTRA INC	ENCLOMIPHENE CITRATE
28947	A	II	1/20/2015	PCAS	CLOMIPHENE CITRATE
29195	A	II	4/16/2015	PCAS	ENCLOMIPHENE CITRATE
31739	A	II	5/25/2017	FIS FABBRICA ITALIANA SINTETICI SPA	ENCLOMIPHENE CITRATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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