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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 218194

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NDA 218194 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 218194

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

Pharmacology for NDA: 218194

Medical Subject Heading (MeSH) Categories for 218194

Dermatologic Agents
Teratogens

Suppliers and Packaging for NDA: 218194

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	218194	ANDA	Aurobindo Pharma Limited	59651-631	59651-631-03	3 BLISTER PACK in 1 CARTON (59651-631-03) / 10 CAPSULE in 1 BLISTER PACK
ISOTRETINOIN	isotretinoin	CAPSULE;ORAL	218194	ANDA	Aurobindo Pharma Limited	59651-632	59651-632-03	3 BLISTER PACK in 1 CARTON (59651-632-03) / 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Jan 29, 2024	TE:	AB2	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	20MG
Approval Date:	Jan 29, 2024	TE:	AB2	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Jan 29, 2024	TE:	AB2	RLD:	No

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