You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

Details for New Drug Application (NDA): 203180


✉ Email this page to a colleague

« Back to Dashboard


NDA 203180 describes DASATINIB, which is a drug marketed by Apotex and is included in two NDAs. It is available from one supplier. Additional details are available on the DASATINIB profile page.

The generic ingredient in DASATINIB is dasatinib. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dasatinib profile page.
Summary for 203180
Tradename:DASATINIB
Applicant:Apotex
Ingredient:dasatinib
Patents:0
Pharmacology for NDA: 203180
Medical Subject Heading (MeSH) Categories for 203180
Suppliers and Packaging for NDA: 203180
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DASATINIB dasatinib TABLET;ORAL 203180 ANDA Apotex Corp. 60505-3816 60505-3816-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-3816-3)
DASATINIB dasatinib TABLET;ORAL 203180 ANDA Apotex Corp. 60505-3817 60505-3817-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-3817-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Nov 23, 2021TE:ABRLD:No
Regulatory Exclusivity Expiration:Mar 2, 2025
Regulatory Exclusivity Use:PATENT CHALLENGE

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength140MG
Approval Date:Nov 23, 2021TE:ABRLD:No
Regulatory Exclusivity Expiration:Mar 2, 2025
Regulatory Exclusivity Use:PATENT CHALLENGE

Complete Access Available with Subscription

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

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.