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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 212932


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NDA 212932 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.
Summary for 212932
Tradename:EPHEDRINE SULFATE
Applicant:Amneal
Ingredient:ephedrine sulfate
Patents:0
Pharmacology for NDA: 212932
Suppliers and Packaging for NDA: 212932
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPHEDRINE SULFATE ephedrine sulfate SOLUTION;INTRAVENOUS 212932 ANDA NorthStar Rx LLC 16714-037 16714-037-10 10 VIAL, SINGLE-DOSE in 1 CARTON (16714-037-10) / 1 mL in 1 VIAL, SINGLE-DOSE (16714-037-01)
EPHEDRINE SULFATE ephedrine sulfate SOLUTION;INTRAVENOUS 212932 ANDA Amneal Pharmaceuticals LLC 70121-1637 70121-1637-5 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1637-5) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1637-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength50MG/ML (50MG/ML)
Approval Date:Oct 23, 2019TE:APRLD:No

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