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Generated: November 13, 2018

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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 two suppliers. Additional details are available on the AKOVAZ profile page.

The generic ingredient in AKOVAZ is ephedrine sulfate. There are sixty-eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ephedrine sulfate profile page.
Summary for 208289
Tradename:AKOVAZ
Applicant:Flamel Ireland Ltd
Ingredient:ephedrine sulfate
Patents:0
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 BluePoint Laboratories 68001-330 68001-330-60 25 VIAL, SINGLE-DOSE in 1 CARTON (68001-330-60) > 1 mL in 1 VIAL, SINGLE-DOSE (68001-330-59)
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)

Profile 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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