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Last Updated: March 28, 2024

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. Eighteen suppliers are listed for this compound. Additional details are available on the ephedrine sulfate profile page.
Summary for 208289
Tradename:AKOVAZ
Applicant:Exela Pharma
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 Exela Pharma Sciences, LLC 51754-4200 51754-4200-4 25 VIAL, SINGLE-DOSE in 1 CARTON (51754-4200-4) / 1 mL in 1 VIAL, SINGLE-DOSE
AKOVAZ ephedrine sulfate SOLUTION;INTRAVENOUS 208289 NDA Exela Pharma Sciences, LLC 51754-4250 51754-4250-3 10 SYRINGE, PLASTIC in 1 CARTON (51754-4250-3) / 5 mL in 1 SYRINGE, PLASTIC

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength25MG/5ML (5MG/ML)
Approval Date:Aug 2, 2021TE:RLD:Yes

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