Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205029

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EPINEPHRINE (EPINEPHRINE)
10MG/10ML (1MG/ML)
Marketing Status: Prescription

Active Ingredient: EPINEPHRINE
Proprietary Name: EPINEPHRINE
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Strength: 10MG/10ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205029
Product Number: 002
Approval Date: Feb 4, 2022
Applicant Holder Full Name: BPI LABS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

EPINEPHRINE (EPINEPHRINE)
1MG/ML (1MG/ML)
Marketing Status: Prescription

Active Ingredient: EPINEPHRINE
Proprietary Name: EPINEPHRINE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS
Strength: 1MG/ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205029
Product Number: 001
Approval Date: Jul 29, 2014
Applicant Holder Full Name: BPI LABS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information