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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213994

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EPHEDRINE SULFATE (EPHEDRINE SULFATE)
25MG/5ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: EPHEDRINE SULFATE
Proprietary Name: EPHEDRINE SULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 25MG/5ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213994
Product Number: 002
Approval Date: Apr 22, 2022
Applicant Holder Full Name: ENDO VENTURES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
EPHEDRINE SULFATE (EPHEDRINE SULFATE)
50MG/10ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: EPHEDRINE SULFATE
Proprietary Name: EPHEDRINE SULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50MG/10ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213994
Product Number: 001
Approval Date: Oct 16, 2020
Applicant Holder Full Name: ENDO VENTURES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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