Drug Master Files for: NORGESTREL

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NORGESTREL Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10218	A	II	5/4/1993	BAYER OY	NORPLANT (LEVONORGESTREL IMPLANTS)
12934	I	II	3/20/1998	YANGZHOU PHARMACEUTICAL FACTORY	LEVONORGESTREL USP 23
12994	I	II	5/18/1998	HUBEI PHARMACEUTICAL FACTORY	LEVONORGESTREL, USP
14288	I	II	7/12/1999	HOECHST MARION ROUSSEL	LEVONORGESTREL
14923	A	II	6/16/2000	3M DRUG DELIVERY SYSTEMS	CLIMARA PRO(R) ESTRADIOL/LEVONORGESTREL TRANSDERMAL DELIVERY SYSTEM
16271	A	II	11/26/2002	GADOR SA	NORGESTIMATE- DEXNORGESTREL ACETIME
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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