Generated: August 17, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 091665
, which is a drug marketed by Fresenius Kabi Usa, Hospira Inc, Mylan Institutional, Hikma Pharm Co Ltd, Par Sterile Products, Novartis Pharms Corp, Teva Pharms Usa, Sandoz, Eagle Pharms, and Gland Pharma Ltd, and is included in eleven 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. Nine suppliers are listed for this compound. Additional details are available on the argatroban profile page.
Summary for NDA: 091665
|Formulation / Manufacturing:||see details|
Suppliers and Packaging for NDA: 091665
||National Drug Code
||Par Pharmaceutical, Inc.
||1 VIAL in 1 CARTON (42023-182-01) > 2.5 mL in 1 VIAL
|Complete Access Available with Subscription
Summary for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||INJECTABLE;INJECTION||Strength||250MG/2.5ML (100MG/ML)|
|Approval Date:||Jun 30, 2014||TE:||AP||RLD:||No|
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