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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 207792


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NDA 207792 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 six 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. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
Summary for 207792
Tradename:ISOTRETINOIN
Applicant:Amneal Pharms Ny
Ingredient:isotretinoin
Patents:0
Pharmacology for NDA: 207792
Medical Subject Heading (MeSH) Categories for 207792
Suppliers and Packaging for NDA: 207792
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOTRETINOIN isotretinoin CAPSULE;ORAL 207792 ANDA Amneal Pharmaceuticals NY LLC 69238-1017 69238-1017-3 3 BLISTER PACK in 1 CARTON (69238-1017-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1017-1)
ISOTRETINOIN isotretinoin CAPSULE;ORAL 207792 ANDA Amneal Pharmaceuticals NY LLC 69238-1174 69238-1174-3 3 BLISTER PACK in 1 CARTON (69238-1174-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69238-1174-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Sep 29, 2017TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Sep 29, 2017TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Sep 29, 2017TE:AB1RLD:No

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