You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School

Last Updated: April 22, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202547

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 202547 describes ARIPIPRAZOLE, which is a drug marketed by Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Lannett Co Inc, Vistapharm, Alembic Pharms Ltd, Orchid Hlthcare, Sciegen Pharms Inc, Zydus Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Boscogen, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Prinston Inc, Teva Pharms Usa, and Torrent, and is included in twenty-eight NDAs. It is available from forty-one 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-three suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 202547
Applicant:Orchid Hlthcare
Formulation / Manufacturing:see details
Pharmacology for NDA: 202547
Medical Subject Heading (MeSH) Categories for 202547
Suppliers and Packaging for NDA: 202547
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIPIPRAZOLE aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 202547 ANDA OrchidPharma Inc 42043-400 42043-400-03 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (42043-400-03)
ARIPIPRAZOLE aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 202547 ANDA OrchidPharma Inc 42043-401 42043-401-03 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (42043-401-03)

Profile for product number 001

Approval Date:Dec 11, 2017TE:ABRLD:No

Profile for product number 002

Approval Date:Dec 11, 2017TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School

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 verification 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.