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Details for New Drug Application (NDA): 203049

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NDA 203049 describes ARGATROBAN, which is a drug marketed by Fresenius Kabi Usa, Hospira Inc, Mylan Institutional, Hikma Pharm Co Ltd, Par Sterile Products, Pfizer, Teva Pharms Usa, Sandoz, and Eagle Pharms, and is included in ten NDAs. It is available from five 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. 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: 203049

Formulation / Manufacturing:see details

Pharmacology for NDA: 203049

Mechanism of ActionThrombin Inhibitors

Suppliers and Packaging for NDA: 203049

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 203049 NDA West-Ward Pharmaceuticals Corp 0143-9559 0143-9559-01 1 VIAL in 1 CARTON (0143-9559-01) > 50 mL in 1 VIAL
INJECTABLE;INJECTION 203049 NDA West-Ward Pharmaceuticals Corp 0143-9674 0143-9674-01 2.5 mL in 1 VIAL (0143-9674-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250MG/2.5ML (100MG/ML)
Approval Date:Jan 5, 2012TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/50ML (1MG/ML)
Approval Date:Sep 30, 2016TE:RLD:Yes

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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.