Details for New Drug Application (NDA): 213994
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NDA 213994 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 213994
| Tradename: | EPHEDRINE SULFATE |
| Applicant: | Endo Operations |
| Ingredient: | ephedrine sulfate |
| Patents: | 2 |
Pharmacology for NDA: 213994
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Increased Norepinephrine Activity |
Medical Subject Heading (MeSH) Categories for 213994
Suppliers and Packaging for NDA: 213994
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPHEDRINE SULFATE | ephedrine sulfate | SOLUTION;INTRAVENOUS | 213994 | NDA | ENDO USA, Inc. | 42023-243 | 42023-243-01 | 10 mL in 1 VIAL, SINGLE-DOSE (42023-243-01) |
| EPHEDRINE SULFATE | ephedrine sulfate | SOLUTION;INTRAVENOUS | 213994 | NDA | ENDO USA, Inc. | 42023-243 | 42023-243-99 | 10 mL in 1 VIAL, SINGLE-DOSE (42023-243-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/10ML (5MG/ML) | ||||
| Approval Date: | Oct 16, 2020 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 22, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 25MG/5ML (5MG/ML) | ||||
| Approval Date: | Apr 22, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 22, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 22, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF CLINICALLY IMPORTANT HYPOTENSION OCCURRING IN THE SETTING OF ANESTHESIA | ||||||||
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