Drug Master Files for: CORTICOTROPIN

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CORTICOTROPIN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11078	A	II	9/10/1994	BACHEM AMERICAS INC	OVINE CORTICOTROPIN RELEASING FACTOR (0CRF)
1780	I	II	8/21/1971	FREDERIKSBERG CHEMICAL LABORATORIES LTD	CORTICOTROPIN (ACTH)
21473	A	II	3/28/2008	POLYPEPTIDE LABORATORIES INC	ALPHA-CORTICOTROPIN (1-24) ACETATE
25341	A	II	9/28/2011	MALLINCKRODT INC	H.P. ACTHAR GEL (REPOSITORY CORTICOTROPIN INJECTION)
278	I	II	10/28/1957	ORTHANA KEMISK FABRIK A S	CORTICOTROPIN - GEL
4181	I	II	6/10/1981	MERCK SHARP AND DOHME BV	CORTICOTROPIN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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