Details for New Drug Application (NDA): 218271
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NDA 218271 describes EPHEDRINE SULFATE, which is a drug marketed by Amneal, Caplin, 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 seventeen NDAs. It is available from nineteen 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-three 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-three suppliers are listed for this compound. Additional details are available on the ephedrine sulfate profile page.
Summary for 218271
| Tradename: | EPHEDRINE SULFATE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | ephedrine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 218271
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Increased Norepinephrine Activity |
Medical Subject Heading (MeSH) Categories for 218271
Suppliers and Packaging for NDA: 218271
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPHEDRINE SULFATE | ephedrine sulfate | SOLUTION;INTRAVENOUS | 218271 | ANDA | Fresenius Kabi USA, LLC | 65219-546 | 65219-546-05 | 10 SYRINGE, PLASTIC in 1 CARTON (65219-546-05) / 5 mL in 1 SYRINGE, PLASTIC (65219-546-01) |
| EPHEDRINE SULFATE | ephedrine sulfate | SOLUTION;INTRAVENOUS | 218271 | ANDA | Fresenius Kabi USA, LLC | 65219-548 | 65219-548-10 | 10 SYRINGE, PLASTIC in 1 CARTON (65219-548-10) / 10 mL in 1 SYRINGE, PLASTIC (65219-548-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 25MG/5ML (5MG/ML) | ||||
| Approval Date: | Mar 11, 2025 | TE: | AP2 | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Feb 21, 2026 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/10ML (5MG/ML) | ||||
| Approval Date: | Mar 11, 2025 | TE: | AP2 | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Feb 21, 2026 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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