Drug Master Files for: norethindrone

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norethindrone Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10185	A	II	4/12/1993	ASPEN OSS BV	NORETHINDRONE ACETATE
10542	I	II	10/25/1993	CYGNUS INC	ESTRADIOL-NORETHINDRONE TRANSDERMAL DELIVERY SYSTEM
1084	I	II	9/13/1967	SYNTEX USA INC	NORETHINDRONE ACETATE
1846	I	II	12/22/1971	ROUSSEL CORP	NORETHINDRONE 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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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