Last Updated: November 8, 2026

Details for New Drug Application (NDA): 220336

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NDA 220336 describes ISOTRETINOIN, which is a drug marketed by Actavis Labs Fl, Amneal Pharms Ny, Aurobindo Pharma, Aurobindo Pharma Ltd, Upsher Smith Labs, and Zydus Pharms, and is included in nine NDAs. It is available from seven suppliers. Additional details are available on the ISOTRETINOIN profile page.

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

Summary for 220336

Tradename:	ISOTRETINOIN
Applicant:	Aurobindo Pharma Ltd
Ingredient:	isotretinoin
Patents:	0

Pharmacology for NDA: 220336

Medical Subject Heading (MeSH) Categories for 220336

Dermatologic Agents
Teratogens

Suppliers and Packaging for NDA: 220336

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	220336	ANDA	Aurobindo Pharma Limited	84386-009	84386-009-03	3 BLISTER PACK in 1 CARTON (84386-009-03) / 10 CAPSULE in 1 BLISTER PACK
ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	220336	ANDA	Aurobindo Pharma Limited	84386-010	84386-010-03	3 BLISTER PACK in 1 CARTON (84386-010-03) / 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	20MG
Approval Date:	Sep 10, 2026	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Sep 10, 2026	TE:	AB1	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	40MG
Approval Date:	Sep 10, 2026	TE:	AB1	RLD:	No

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