Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Product Details for NDA 019430

EPIPEN (EPINEPHRINE)
0.3MG/DELIVERY
Marketing Status: Prescription

Active Ingredient: EPINEPHRINE
Proprietary Name: EPIPEN
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR, SUBCUTANEOUS
Strength: 0.3MG/DELIVERY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019430
Product Number: 001
Approval Date: Dec 22, 1987
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status: Prescription
Patent and Exclusivity Information

EPIPEN JR. (EPINEPHRINE)
0.15MG/DELIVERY
Marketing Status: Prescription

Active Ingredient: EPINEPHRINE
Proprietary Name: EPIPEN JR.
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR, SUBCUTANEOUS
Strength: 0.15MG/DELIVERY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019430
Product Number: 002
Approval Date: Dec 22, 1987
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status: Prescription
Patent and Exclusivity Information

EPI E Z PEN JR (EPINEPHRINE)
0.15MG/DELIVERY
Marketing Status: Discontinued

Active Ingredient: EPINEPHRINE
Proprietary Name: EPI E Z PEN JR
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR
Strength: 0.15MG/DELIVERY
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019430
Product Number: 004
Approval Date: Aug 3, 1995
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status: Discontinued
Patent and Exclusivity Information

EPIPEN E Z PEN (EPINEPHRINE)
0.3MG/DELIVERY
Marketing Status: Discontinued

Active Ingredient: EPINEPHRINE
Proprietary Name: EPIPEN E Z PEN
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR
Strength: 0.3MG/DELIVERY
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N019430
Product Number: 003
Approval Date: Aug 3, 1995
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status: Discontinued
Patent and Exclusivity Information