Details for New Drug Application (NDA): 216146
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NDA 216146 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 216146
| Tradename: | EPHEDRINE SULFATE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | ephedrine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 216146
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Increased Norepinephrine Activity |
Medical Subject Heading (MeSH) Categories for 216146
Suppliers and Packaging for NDA: 216146
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPHEDRINE SULFATE | ephedrine sulfate | SOLUTION;INTRAVENOUS | 216146 | ANDA | Gland Pharma Limited | 68083-495 | 68083-495-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (68083-495-25) / 1 mL in 1 VIAL, SINGLE-DOSE |
| EPHEDRINE SULFATE | ephedrine sulfate | SOLUTION;INTRAVENOUS | 216146 | ANDA | Somerset Therapeutics, LLC | 70069-819 | 70069-819-10 | 10 VIAL in 1 CARTON (70069-819-10) / 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: | Feb 25, 2022 | TE: | AP | RLD: | No | ||||
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