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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 205363


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NDA 205363 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-six 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. Forty-nine suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 205363
Tradename:ARIPIPRAZOLE
Applicant:Prinston Inc
Ingredient:aripiprazole
Patents:0
Pharmacology for NDA: 205363
Medical Subject Heading (MeSH) Categories for 205363
Suppliers and Packaging for NDA: 205363
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIPIPRAZOLE aripiprazole TABLET;ORAL 205363 ANDA Solco Healthcare U.S., LLC 43547-302 43547-302-03 30 TABLET in 1 BOTTLE (43547-302-03)
ARIPIPRAZOLE aripiprazole TABLET;ORAL 205363 ANDA Solco Healthcare U.S., LLC 43547-302 43547-302-09 90 TABLET in 1 BOTTLE (43547-302-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Dec 4, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 4, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 4, 2017TE:ABRLD:No

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