BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Chinese Patent Office
US Department of Justice
US Army

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208289

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NDA 208289 describes AKOVAZ, which is a drug marketed by Flamel Ireland Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the AKOVAZ profile page.

The generic ingredient in AKOVAZ is ephedrine sulfate. There are sixty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ephedrine sulfate profile page.

Summary for 208289

Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 208289

Suppliers and Packaging for NDA: 208289

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AKOVAZ ephedrine sulfate SOLUTION;INTRAVENOUS 208289 NDA Avadel Legacy Pharmaceuticals, LLC 76014-005 76014-005-25 25 VIAL, SINGLE-DOSE in 1 CARTON (76014-005-25) > 1 mL in 1 VIAL, SINGLE-DOSE (76014-005-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength50MG/ML (50MG/ML)
Approval Date:Apr 29, 2016TE:APRLD:Yes

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Johnson and Johnson
Chinese Patent Office
Argus Health

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