You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 16, 2025

Details for New Drug Application (NDA): 076503

✉ Email this page to a colleague

« Back to Dashboard

NDA 076503 describes SOTRET, which is a drug marketed by Sun Pharm Inds Ltd and is included in two NDAs. Additional details are available on the SOTRET profile page.

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

Summary for 076503

Tradename:	SOTRET
Applicant:	Sun Pharm Inds Ltd
Ingredient:	isotretinoin
Patents:	0

Medical Subject Heading (MeSH) Categories for 076503

Dermatologic Agents
Teratogens

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Jun 20, 2003	TE:		RLD:	No

Complete Access Available with Subscription

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.