Last Updated: September 1, 2026

Details for New Drug Application (NDA): 076503

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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 is one drug master file entry for this compound. Fourteen 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

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