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Serving leading biopharmaceutical companies globally:

Julphar
Federal Trade Commission
Moodys
Mallinckrodt
Medtronic
Argus Health
Cantor Fitzgerald
Cerilliant
McKinsey
Johnson and Johnson

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018662

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NDA 018662 describes ACCUTANE, which is a drug marketed by Hoffmann La Roche and is included in one NDA. Additional details are available on the ACCUTANE profile page.

The generic ingredient in ACCUTANE is isotretinoin. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.

Summary for 018662

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 018662

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 7, 1982TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 7, 1982TE:RLD:Yes

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 28, 1983TE:RLD:Yes

Expired Orange Book Patents for NDA: 018662

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-004Mar 28, 1983► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-002May 7, 1982► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-003May 7, 1982► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-003May 7, 1982► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-004Mar 28, 1983► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-004Mar 28, 1983► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-003May 7, 1982► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-004Mar 28, 1983► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-002May 7, 1982► Subscribe► Subscribe
Hoffmann La RocheACCUTANEisotretinoinCAPSULE;ORAL018662-002May 7, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Citi
Boehringer Ingelheim
Daiichi Sankyo
Chinese Patent Office
AstraZeneca
Healthtrust
Merck
Farmers Insurance
Fuji
Dow

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.

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