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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 213718


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NDA 213718 describes BREXPIPRAZOLE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Lupin Ltd, Optimus, Sandoz, Teva Pharms Usa Inc, and Zydus Pharms, and is included in ten NDAs. It is available from two suppliers. Additional details are available on the BREXPIPRAZOLE profile page.

The generic ingredient in BREXPIPRAZOLE is brexpiprazole. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the brexpiprazole profile page.
Summary for 213718
Tradename:BREXPIPRAZOLE
Applicant:Ajanta Pharma Ltd
Ingredient:brexpiprazole
Patents:0
Pharmacology for NDA: 213718
Suppliers and Packaging for NDA: 213718
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BREXPIPRAZOLE brexpiprazole TABLET;ORAL 213718 ANDA Ajanta Pharma USA Inc. 27241-204 27241-204-30 30 TABLET in 1 BOTTLE (27241-204-30)
BREXPIPRAZOLE brexpiprazole TABLET;ORAL 213718 ANDA Ajanta Pharma USA Inc. 27241-205 27241-205-30 30 TABLET in 1 BOTTLE (27241-205-30)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.25MG
Approval Date:Feb 3, 2023TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.5MG
Approval Date:Feb 3, 2023TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG
Approval Date:Feb 3, 2023TE:RLD:No

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