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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203883

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NDA 203883 describes ADENOSINE, which is a drug marketed by Akorn, Fresenius Kabi Usa, Gland Pharma Ltd, Luitpold, Mylan Labs Ltd, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Aurobindo Pharma Ltd, Emcure Pharms Ltd, Hospira Inc, and Sagent Strides, and is included in eighteen NDAs. It is available from seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the adenosine profile page.

Summary for 203883

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 203883

Mechanism of ActionAdenosine Receptor Agonists

Medical Subject Heading (MeSH) Categories for 203883

Suppliers and Packaging for NDA: 203883

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADENOSINE adenosine SOLUTION;IV (INFUSION) 203883 ANDA Hospira, Inc. 0409-1932 0409-1932-02 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1932-02) > 30 mL in 1 VIAL, SINGLE-DOSE
ADENOSINE adenosine SOLUTION;IV (INFUSION) 203883 ANDA Hospira, Inc. 0409-1932 0409-1932-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1932-01) > 20 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength60MG/20ML (3MG/ML)
Approval Date:Mar 24, 2014TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength90MG/30ML (3MG/ML)
Approval Date:Mar 24, 2014TE:APRLD:No


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