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

Last Updated: November 26, 2024

Details for New Drug Application (NDA): 214235


✉ Email this page to a colleague

« Back to Dashboard


NDA 214235 describes ARGATROBAN, which is a drug marketed by Amneal Pharms Co, Caplin, Endo Operations, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Pharm Co Ltd, Hospira, Mylan Institutional, Sandoz, Teva Pharms Usa, Cipla, Accord Hlthcare, and Eugia Pharma Speclts, and is included in sixteen NDAs. It is available from nine suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ARGATROBAN profile page.

The generic ingredient in ARGATROBAN is argatroban. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the argatroban profile page.
Summary for 214235
Tradename:ARGATROBAN
Applicant:Caplin
Ingredient:argatroban
Patents:0
Pharmacology for NDA: 214235
Mechanism of ActionThrombin Inhibitors
Suppliers and Packaging for NDA: 214235
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARGATROBAN argatroban INJECTABLE;INJECTION 214235 ANDA Sagent Pharmaceuticals 25021-414 25021-414-50 1 VIAL in 1 CARTON (25021-414-50) / 50 mL in 1 VIAL
ARGATROBAN argatroban INJECTABLE;INJECTION 214235 ANDA Caplin Steriles Limited 65145-126 65145-126-01 1 VIAL in 1 CARTON (65145-126-01) / 50 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/50ML (1MG/ML)
Approval Date:Jan 21, 2021TE:APRLD:No

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.