Drug Master Files for: HYDROXYPROGESTERONE CAPROATE

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HYDROXYPROGESTERONE CAPROATE Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
17113	A	II	1/21/2004	ASPEN OSS BV	HYDROXYPROGESTERONE CAPROATE
2856	I	II	2/16/1977	UPJOHN CO	HYDROXYPROGESTERONE CAPROATE
28958	A	II	2/6/2015	SUN PHARMACEUTICAL INDUSTRIES LTD	HYDROXYPROGESTERONE CAPROATE USP
29030	A	II	1/20/2015	SYMBIOTEC PHARMALAB PRIVATE LTD	17-a HYDROXYPROGESTERONE (INTERMEDIATE)
2993	I	II	7/18/1977	DIOSYNTH BV	HYDROXYPROGESTERONE CAPROATE
30747	A	II	7/19/2016	SYMBIOTEC PHARMALAB PRIVATE LTD	HYDROXYPROGESTERONE CAPROATE USP
31337	A	II	1/18/2017	STEROID SPA	HYDROXYPROGESTERONE CAPROATE
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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