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Last Updated: January 17, 2021

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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 Exela Pharma 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-eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ephedrine sulfate profile page.
Summary for 208289
Applicant:Exela Pharma
Ingredient:ephedrine sulfate
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)

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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