Details for New Drug Application (NDA): 217721
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NDA 217721 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 217721
| Tradename: | EPHEDRINE SULFATE |
| Applicant: | Hikma |
| Ingredient: | ephedrine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 217721
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Increased Norepinephrine Activity |
Medical Subject Heading (MeSH) Categories for 217721
Suppliers and Packaging for NDA: 217721
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPHEDRINE SULFATE | ephedrine sulfate | SOLUTION;INTRAVENOUS | 217721 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6236 | 0641-6236-10 | 10 SYRINGE, PLASTIC in 1 CARTON (0641-6236-10) / 5 mL in 1 SYRINGE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 25MG/5ML (5MG/ML) | ||||
| Approval Date: | Oct 11, 2024 | TE: | AP3 | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jun 18, 2025 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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