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Details for New Drug Application (NDA): 202101

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NDA 202101 describes ARIPIPRAZOLE, which is a drug marketed by Alembic Pharms Ltd, Amneal Pharms, Teva Pharms Usa, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Torrent Pharms Ltd, Hetero Labs Ltd V, Silarx Pharms Inc, Ajanta Pharma Ltd, Apotex Inc, and Sciegen Pharms Inc, and is included in sixteen NDAs. It is available from twenty-four suppliers. Additional details are available on the ARIPIPRAZOLE profile page.

The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. There are sixteen tentative approvals for this compound. Additional details are available on the aripiprazole profile page.

Summary for NDA: 202101

Alembic Pharms Ltd
Therapeutic Class:Antipsychotics
Bipolar Agents

Pharmacology for NDA: 202101

Suppliers and Packaging for NDA: 202101

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 202101 ANDA Trigen Laboratories, LLC 13811-679 13811-679-01 1000 TABLET in 1 BOTTLE (13811-679-01)
TABLET;ORAL 202101 ANDA Trigen Laboratories, LLC 13811-679 13811-679-10 100 TABLET in 1 BOTTLE (13811-679-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Apr 28, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 28, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 28, 2015TE:ABRLD:No

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