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Last Updated: November 2, 2024

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 seventeen 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-one 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
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:RXDosage:SOLUTION;INTRAVENOUSStrength50MG/10ML (5MG/ML)
Approval Date:Oct 16, 2020TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 22, 2040Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength25MG/5ML (5MG/ML)
Approval Date:Apr 22, 2022TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 22, 2040Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jan 22, 2040Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CLINICALLY IMPORTANT HYPOTENSION OCCURRING IN THE SETTING OF ANESTHESIA

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