Details for New Drug Application (NDA): 208289
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The generic ingredient in AKOVAZ is ephedrine sulfate. There are sixty-eight drug master file entries for this compound. Twenty-one 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 |
Pharmacology for NDA: 208289
Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Physiological Effect | Increased Norepinephrine Activity |
Medical Subject Heading (MeSH) Categories for 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: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/ML (50MG/ML) | ||||
Approval Date: | Apr 29, 2016 | TE: | AP | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 25MG/5ML (5MG/ML) | ||||
Approval Date: | Aug 2, 2021 | TE: | RLD: | Yes |
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