Details for New Drug Application (NDA): 209646
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NDA 209646 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 fourteen NDAs. It is available from eighteen 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-two 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-two suppliers are listed for this compound. Additional details are available on the ephedrine sulfate profile page.
Summary for 209646
| Tradename: | EPHEDRINE SULFATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | ephedrine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 209646
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Increased Norepinephrine Activity |
Medical Subject Heading (MeSH) Categories for 209646
Suppliers and Packaging for NDA: 209646
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPHEDRINE SULFATE | ephedrine sulfate | SOLUTION;INTRAVENOUS | 209646 | ANDA | Fresenius Kabi USA, LLC | 65219-257 | 65219-257-01 | 25 VIAL, GLASS in 1 CARTON (65219-257-01) / 1 mL in 1 VIAL, GLASS (65219-257-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/ML (50MG/ML) | ||||
| Approval Date: | Aug 4, 2020 | TE: | AP | RLD: | No | ||||
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