Drug Master Files for: isotretinoin

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isotretinoin Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
13071	I	II	7/1/1998	BASF AKTIENGESELLSCHAFT	9-Z-ISOTRETINOIN
14493	I	II	10/14/1999	RP SCHERER NORTH AMERICA	ACCUTANE (ISOTRETINOIN)
15169	I	II	11/29/2000	SUN PHARMACEUTICAL INDUSTRIES LTD	ISOTRETINOIN USP (NON-STERILE BULK)
19191	A	II	10/25/2005	JIANGXI HENGXIANG PHARMCEUTICAL TECHNOLOGY CO LTD	ISOTRETINOIN (NON-STERILE BULK FORM)
19918	A	II	10/30/2006	HELSINN ADVANCED SYNTHESIS SA	ISOTRETINOIN
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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