.

Make Better Decisions

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

US Army
Baxter
Deloitte
Federal Trade Commission
Colorcon
Chinese Patent Office
Fish and Richardson
Accenture
Chubb
McKesson

Generated: December 16, 2017

DrugPatentWatch Database Preview

Drug Master Files for: isotretinoin

« Back to Dashboard


DMF No. Status Type Submission Date Holder Subject
4676AII9/27/1982SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH13-CIS-RETINOIC ACID (ISOTRETINOIN)
4887III3/23/1983EASTMAN KODAK CO13-Cis-RETINOIC ACID (ISOTRETINOIN)
7485AII5/16/1988OLON SPAISOTRETINOIN
13071III7/1/1998BASF AKTIENGESELLSCHAFT9-Z-ISOTRETINOIN
14493III10/14/1999RP SCHERER NORTH AMERICAACCUTANE (ISOTRETINOIN)
15169AII11/29/2000SUN PHARMACEUTICAL INDUSTRIES LTDISOTRETINOIN USP (NON-STERILE BULK)
19191AII10/25/2005JIANGXI HENGXIANG PHARMCEUTICAL TECHNOLOGY CO LTDISOTRETINOIN (NON-STERILE BULK FORM)
19918AII10/30/2006HELSINN ADVANCED SYNTHESIS SAISOTRETINOIN
21653AII5/23/2008CHONGQING HUAPONT PHARMACEUTICAL CO LTDISOTRETINOIN
22616III6/30/2009IPCA LABORATORIES LTDISOTRETINOIN USP
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.


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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
McKesson
Citi
Chinese Patent Office
Cipla
QuintilesIMS
Harvard Business School
Dow
Cerilliant
Covington

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 verifification 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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot