Drug Master Files for: ulipristal acetate

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ulipristal acetate Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
21527	A	II	4/11/2008	CRYSTAL PHARMA SAU	ULIPRISTAL ACETATE MICRONIZED
25701	A	II	1/9/2012	FORMOSA LABORATORIES INC	ULIPRISTAL ACETATE
26861	A	II	2/4/2013	GEDEON RICHTER PLC	ULIPRISTAL ACETATE MICRONIZED
27945	A	II	4/13/2014	TEVA PHARMACEUTICAL INDUSTRIES LTD	ULIPRISTAL ACETATE
32234	A	II	11/17/2017	NEWCHEM SPA	ULIPRISTAL ACETATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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