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Last Updated: December 24, 2024

Details for New Drug Application (NDA): 204838


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NDA 204838 describes ARIPIPRAZOLE, which is a drug marketed by Amneal Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Lannett Co Inc, Rubicon, Vistapharm, Alembic, Orbion Pharms, Sciegen Pharms Inc, Square Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Aurobindo Pharma, Breckenridge, Hetero Labs Ltd V, Lupin, Macleods Pharms Ltd, Norvium Bioscience, Prinston Inc, Sunshine, Teva Pharms Usa, Torrent, Unichem, and Zydus Pharms, and is included in thirty-four NDAs. It is available from forty-seven suppliers. Additional details are available on the ARIPIPRAZOLE profile page.

The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-nine drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 204838
Tradename:ARIPIPRAZOLE
Applicant:Amneal Pharms
Ingredient:aripiprazole
Patents:0
Pharmacology for NDA: 204838
Medical Subject Heading (MeSH) Categories for 204838
Suppliers and Packaging for NDA: 204838
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIPIPRAZOLE aripiprazole TABLET;ORAL 204838 ANDA Major Pharmaceuticals 0904-7366 0904-7366-04 30 BLISTER PACK in 1 CARTON (0904-7366-04) / 1 TABLET in 1 BLISTER PACK
ARIPIPRAZOLE aripiprazole TABLET;ORAL 204838 ANDA Major Pharmaceuticals 0904-7367 0904-7367-06 50 BLISTER PACK in 1 CARTON (0904-7367-06) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jun 17, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 17, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 17, 2016TE:ABRLD:No

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