Make Better Decisions

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Julphar
Farmers Insurance
Cerilliant
US Department of Justice
McKesson
Medtronic
Boehringer Ingelheim
Daiichi Sankyo
Federal Trade Commission
Teva

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202101

« Back to Dashboard

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

The generic ingredient in ARIPIPRAZOLE is aripiprazole. There are forty-five drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 202101
Tradename:ARIPIPRAZOLE
Applicant:Alembic Pharms Ltd
Ingredient:aripiprazole
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202101
Medical Subject Heading (MeSH) Categories for 202101
Suppliers and Packaging for NDA: 202101
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIPIPRAZOLE aripiprazole TABLET;ORAL 202101 ANDA Trigen Laboratories, LLC 13811-679 13811-679-10 100 TABLET in 1 BOTTLE (13811-679-10)
ARIPIPRAZOLE aripiprazole TABLET;ORAL 202101 ANDA Trigen Laboratories, LLC 13811-679 13811-679-01 1000 TABLET in 1 BOTTLE (13811-679-01)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Farmers Insurance
QuintilesIMS
Baxter
Healthtrust
Cantor Fitzgerald
Medtronic
Colorcon
Julphar
Fish and Richardson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot