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Details for New Drug Application (NDA): 206174

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NDA 206174 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: 206174

Ajanta Pharma Ltd
Therapeutic Class:Antipsychotics
Bipolar Agents

Pharmacology for NDA: 206174

Suppliers and Packaging for NDA: 206174

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 206174 ANDA Ajanta Pharma Limited 27241-051 27241-051-03 30 TABLET in 1 BOTTLE (27241-051-03)
TABLET;ORAL 206174 ANDA Ajanta Pharma Limited 27241-052 27241-052-03 30 TABLET in 1 BOTTLE (27241-052-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Sep 12, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Sep 12, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 12, 2016TE:ABRLD:No

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