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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205029

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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: N205029
Product Number: 005
Approval Date: Mar 4, 2024
Applicant Holder Full Name: BPI LABS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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: AP
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)
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: N205029
Product Number: 004
Approval Date: Feb 14, 2024
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: AP
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
EPINEPHRINE (EPINEPHRINE)
1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: EPINEPHRINE
Proprietary Name: EPINEPHRINE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1MG/ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205029
Product Number: 003
Approval Date: May 12, 2023
Applicant Holder Full Name: BPI LABS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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