Details for New Drug Application (NDA): 214528
NDA 214528 describes EPHEDRINE SULFATE, which is a drug marketed by Amneal, Baxter Hlthcare Corp, Caplin, Civica, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Mankind Pharma, Ph Health, Renew Pharms, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms, and is included in twenty NDAs. It is available from twenty-one suppliers. There are two patents protecting this drug. Additional details are available on the EPHEDRINE SULFATE profile page.
The generic ingredient in EPHEDRINE SULFATE is ephedrine sulfate. There is one drug master file entry for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ephedrine sulfate profile page.
The generic ingredient in EPHEDRINE SULFATE is ephedrine sulfate. There is one drug master file entry for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ephedrine sulfate profile page.
Summary for 214528
| Tradename: | EPHEDRINE SULFATE |
| Applicant: | Sagent Pharms Inc |
| Ingredient: | ephedrine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 214528
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Increased Norepinephrine Activity |
Medical Subject Heading (MeSH) Categories for 214528
Suppliers and Packaging for NDA: 214528
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPHEDRINE SULFATE | ephedrine sulfate | SOLUTION;INTRAVENOUS | 214528 | ANDA | Sagent Pharmaceuticals | 25021-836 | 25021-836-01 | 25 VIAL in 1 CARTON (25021-836-01) / 1 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/ML (50MG/ML) | ||||
| Approval Date: | Mar 9, 2023 | TE: | AP | RLD: | No | ||||
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