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Last Updated: April 6, 2026

Details for New Drug Application (NDA): 213571

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NDA 213571 describes ISOTRETINOIN, which is a drug marketed by Actavis Labs Fl, Amneal Pharms Ny, Aurobindo Pharma, Upsher Smith Labs, and Zydus Pharms, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the ISOTRETINOIN profile page.

The generic ingredient in ISOTRETINOIN 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 213571

Tradename:	ISOTRETINOIN
Applicant:	Upsher Smith Labs
Ingredient:	isotretinoin
Patents:	0

Pharmacology for NDA: 213571

Medical Subject Heading (MeSH) Categories for 213571

Dermatologic Agents
Teratogens

Suppliers and Packaging for NDA: 213571

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	213571	ANDA	Upsher-Smith Laboratories, LLC	0245-0575	0245-0575-01	3 BLISTER PACK in 1 BOX (0245-0575-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0245-0575-89)
ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	213571	ANDA	Mayne Pharma	68308-575	68308-575-30	3 BLISTER PACK in 1 BOX (68308-575-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-575-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	40MG
Approval Date:	Apr 12, 2021	TE:	AB2	RLD:	No

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