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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 220626

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EPINEPHRINE (EPINEPHRINE)
1MG/ML (1MG/ML)
Marketing Status: Prescription
Active Ingredient: EPINEPHRINE
Proprietary Name: EPINEPHRINE
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Strength: 1MG/ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N220626
Product Number: 001
Approval Date: Mar 30, 2026
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
EPINEPHRINE (EPINEPHRINE)
30MG/30ML (1MG/ML)
Marketing Status: Prescription
Active Ingredient: EPINEPHRINE
Proprietary Name: EPINEPHRINE
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Strength: 30MG/30ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N220626
Product Number: 002
Approval Date: Mar 30, 2026
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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