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Details for New Drug Application (NDA): 206769

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NDA 206769 describes ARGATROBAN IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Teva Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the ARGATROBAN IN 0.9% SODIUM CHLORIDE profile page.

The generic ingredient in ARGATROBAN IN 0.9% SODIUM CHLORIDE is argatroban. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the argatroban profile page.

Summary for NDA: 206769

Formulation / Manufacturing:see details

Pharmacology for NDA: 206769

Mechanism of ActionThrombin Inhibitors

Suppliers and Packaging for NDA: 206769

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;IV (INFUSION) 206769 NDA Teva Parenteral Medicines, Inc. 0703-0020 0703-0020-32 5 BAG in 1 CARTON (0703-0020-32) > 250 mL in 1 BAG (0703-0020-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength250MG/250ML (1MG/ML)
Approval Date:Dec 15, 2014TE:RLD:No

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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.