Drug Master Files for: ISOTRETINOIN

✉ Email this page to a colleague

ISOTRETINOIN Drug Master Files

Subscribe to access the full database, or Sign Up
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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.