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Details for New Drug Application (NDA): 022434

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NDA 022434 describes ARGATROBAN IN SODIUM CHLORIDE, which is a drug marketed by Eagle Pharms and Sandoz and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the ARGATROBAN IN SODIUM CHLORIDE profile page.

The generic ingredient in ARGATROBAN IN SODIUM CHLORIDE is argatroban. There are ten drug master file entries for this compound. Seven 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: 022434

Tradename:
ARGATROBAN IN SODIUM CHLORIDE
Applicant:
Eagle Pharms
Ingredient:
argatroban
Patents:2
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022434

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARGATROBAN IN SODIUM CHLORIDE
argatroban
INJECTABLE;IV (INFUSION) 022434 NDA Sandoz Inc 0781-3314 0781-3314-95 10 CARTON in 1 CARTON (0781-3314-95) > 1 VIAL, SINGLE-USE in 1 CARTON (0781-3314-91) > 50 mL in 1 VIAL, SINGLE-USE
ARGATROBAN IN SODIUM CHLORIDE
argatroban
INJECTABLE;IV (INFUSION) 022434 NDA Sandoz Inc 0781-9314 0781-9314-95 10 CARTON in 1 CARTON (0781-9314-95) > 1 VIAL, SINGLE-USE in 1 CARTON (0781-9314-91) > 50 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/50ML (1MG/ML)
Approval Date:Jun 29, 2011TE:RLD:Yes
Patent:7,687,516Patent Expiration:Sep 26, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING AN ARGATROBAN TREATABLE CONDITION
Patent:7,589,106Patent Expiration:Sep 26, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING THROMBOSIS


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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.

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