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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215875

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ADRENALIN (EPINEPHRINE)
2MG/250ML (8MCG/ML)
Marketing Status: Prescription
Active Ingredient: EPINEPHRINE
Proprietary Name: ADRENALIN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 2MG/250ML (8MCG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215875
Product Number: 001
Approval Date: Apr 21, 2023
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
ADRENALIN (EPINEPHRINE)
4MG/250ML (16MCG/ML)
Marketing Status: Prescription
Active Ingredient: EPINEPHRINE
Proprietary Name: ADRENALIN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 4MG/250ML (16MCG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215875
Product Number: 002
Approval Date: Apr 21, 2023
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
ADRENALIN (EPINEPHRINE)
5MG/250ML (20MCG/ML)
Marketing Status: Prescription
Active Ingredient: EPINEPHRINE
Proprietary Name: ADRENALIN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 5MG/250ML (20MCG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215875
Product Number: 003
Approval Date: Apr 21, 2023
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
ADRENALIN (EPINEPHRINE)
8MG/250ML (32MCG/ML)
Marketing Status: Prescription
Active Ingredient: EPINEPHRINE
Proprietary Name: ADRENALIN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 8MG/250ML (32MCG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215875
Product Number: 004
Approval Date: Apr 21, 2023
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
ADRENALIN (EPINEPHRINE)
10MG/250ML (40MCG/ML)
Marketing Status: Prescription
Active Ingredient: EPINEPHRINE
Proprietary Name: ADRENALIN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10MG/250ML (40MCG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215875
Product Number: 005
Approval Date: Apr 21, 2023
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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