Details for New Drug Application (NDA): 213407
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NDA 213407 describes EMERPHED, which is a drug marketed by Nexus and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the EMERPHED profile page.
The generic ingredient in EMERPHED 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 EMERPHED 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 213407
| Tradename: | EMERPHED |
| Applicant: | Nexus |
| Ingredient: | ephedrine sulfate |
| Patents: | 5 |
Pharmacology for NDA: 213407
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Increased Norepinephrine Activity |
Medical Subject Heading (MeSH) Categories for 213407
Suppliers and Packaging for NDA: 213407
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EMERPHED | ephedrine sulfate | SOLUTION;INTRAVENOUS | 213407 | NDA | Nexus Pharamaceuticals Inc. | 14789-250 | 14789-250-10 | 10 VIAL in 1 CARTON (14789-250-10) / 10 mL in 1 VIAL (14789-250-07) |
| EMERPHED | ephedrine sulfate | SOLUTION;INTRAVENOUS | 213407 | NDA | Nexus Pharmaceuticals, LLC | 14789-251 | 14789-251-10 | 10 SYRINGE in 1 CARTON (14789-251-10) / 5 mL in 1 SYRINGE (14789-251-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/10ML (5MG/ML) | ||||
| Approval Date: | Apr 17, 2020 | TE: | AP1 | RLD: | Yes | ||||
| Patent: | 11,090,278 | Patent Expiration: | May 16, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF EPHEDRINE SULFATE FOR TREATING HYPOTENSION | ||||||||
| Patent: | 11,241,400 | Patent Expiration: | May 16, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF EPHEDRINE SULFATE FOR TREATING HYPOTENSION | ||||||||
| Patent: | 11,464,752 | Patent Expiration: | May 16, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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