Details for New Drug Application (NDA): 215825
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NDA 215825 describes EPHEDRINE SULFATE, which is a drug marketed by Amneal, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Mankind Pharma, Renew Pharms, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms, and is included in fifteen NDAs. It is available from seventeen 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 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.
The generic ingredient in EPHEDRINE SULFATE 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 215825
| Tradename: | EPHEDRINE SULFATE |
| Applicant: | Xiromed |
| Ingredient: | ephedrine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 215825
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Increased Norepinephrine Activity |
Medical Subject Heading (MeSH) Categories for 215825
Suppliers and Packaging for NDA: 215825
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPHEDRINE SULFATE | ephedrine sulfate | SOLUTION;INTRAVENOUS | 215825 | ANDA | Xiromed, LLC | 70700-249 | 70700-249-23 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70700-249-23) / 1 mL in 1 VIAL, SINGLE-DOSE |
| EPHEDRINE SULFATE | ephedrine sulfate | SOLUTION;INTRAVENOUS | 215825 | ANDA | Xiromed, LLC | 70700-249 | 70700-249-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (70700-249-25) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/ML (50MG/ML) | ||||
| Approval Date: | Apr 21, 2022 | TE: | AP | RLD: | No | ||||
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