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. Twenty-three suppliers are listed for this compound. Additional details are available on the ephedrine sulfate profile page.
The generic ingredient in AKOVAZ is ephedrine sulfate. There are sixty-eight drug master file entries for this compound. Twenty-three 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: | AP3 | RLD: | Yes | ||||
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