Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020800

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ADRENACLICK (EPINEPHRINE)
EQ 0.15MG/DELIVERY
Marketing Status: Prescription

Active Ingredient: EPINEPHRINE
Proprietary Name: ADRENACLICK
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR, SUBCUTANEOUS
Strength: EQ 0.15MG/DELIVERY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: BX
Application Number: N020800
Product Number: 003
Approval Date: Nov 25, 2009
Applicant Holder Full Name: IMPAX LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ADRENACLICK (EPINEPHRINE)
EQ 0.3MG/DELIVERY
Marketing Status: Prescription

Active Ingredient: EPINEPHRINE
Proprietary Name: ADRENACLICK
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR, SUBCUTANEOUS
Strength: EQ 0.3MG/DELIVERY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: BX
Application Number: N020800
Product Number: 004
Approval Date: Nov 25, 2009
Applicant Holder Full Name: IMPAX LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

TWINJECT 0.15 (EPINEPHRINE)
EQ 0.15MG/DELIVERY
Marketing Status: Discontinued

Active Ingredient: EPINEPHRINE
Proprietary Name: TWINJECT 0.15
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR, SUBCUTANEOUS
Strength: EQ 0.15MG/DELIVERY
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020800
Product Number: 002
Approval Date: May 28, 2004
Applicant Holder Full Name: IMPAX LABORATORIES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

TWINJECT 0.3 (EPINEPHRINE)
EQ 0.3MG/DELIVERY
Marketing Status: Discontinued

Active Ingredient: EPINEPHRINE
Proprietary Name: TWINJECT 0.3
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR, SUBCUTANEOUS
Strength: EQ 0.3MG/DELIVERY
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020800
Product Number: 001
Approval Date: May 30, 2003
Applicant Holder Full Name: IMPAX LABORATORIES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information