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Generated: April 19, 2019

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Details for New Drug Application (NDA): 202313

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NDA 202313 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 Mylan Asi, and is included in twenty-one NDAs. It is available from nineteen 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. Twenty suppliers are listed for this compound. Additional details are available on the adenosine profile page.
Summary for 202313
Applicant:Emcure Pharms Ltd
Formulation / Manufacturing:see details
Pharmacology for NDA: 202313
Mechanism of ActionAdenosine Receptor Agonists
Medical Subject Heading (MeSH) Categories for 202313
Suppliers and Packaging for NDA: 202313
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADENOSINE adenosine SOLUTION;INTRAVENOUS 202313 ANDA Heritage Pharmaceuticals Inc. 23155-258 23155-258-41 10 VIAL in 1 CARTON (23155-258-41) > 20 mL in 1 VIAL (23155-258-31)
ADENOSINE adenosine SOLUTION;INTRAVENOUS 202313 ANDA Heritage Pharmaceuticals Inc. 23155-258 23155-258-42 10 VIAL in 1 CARTON (23155-258-42) > 30 mL in 1 VIAL (23155-258-32)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength60MG/20ML (3MG/ML)
Approval Date:Sep 15, 2014TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength90MG/30ML (3MG/ML)
Approval Date:Sep 15, 2014TE:APRLD:No

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