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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 078076


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NDA 078076 describes ADENOSINE, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Mylan Labs Ltd, Norvium Bioscience, Rising, Teva Pharms Usa, Wockhardt, Avet Lifesciences, Eugia Pharma, Hospira, Meitheal, and Mylan Asi, and is included in twenty-one NDAs. It is available from twelve suppliers. Additional details are available on the ADENOSINE profile page.

The generic ingredient in ADENOSINE is adenosine. There are twenty-six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the adenosine profile page.
Summary for 078076
Tradename:ADENOSINE
Applicant:Rising
Ingredient:adenosine
Patents:0
Pharmacology for NDA: 078076
Mechanism of ActionAdenosine Receptor Agonists
Medical Subject Heading (MeSH) Categories for 078076
Suppliers and Packaging for NDA: 078076
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADENOSINE adenosine INJECTABLE;INJECTION 078076 ANDA HF Acquisition Co. LLC, DBA Health First 51662-1201 51662-1201-1 2 mL in 1 VIAL (51662-1201-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3MG/ML
Approval Date:Oct 31, 2008TE:APRLD:No

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