Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 201739

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AUVI-Q (EPINEPHRINE)
EQ 0.1MG/DELIVERY Marketing Status: Prescription

Active Ingredient: EPINEPHRINE
Proprietary Name: AUVI-Q
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, SUBCUTANEOUS
Strength: EQ 0.1MG/DELIVERY
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N201739
Product Number: 003
Approval Date: Nov 17, 2017
Applicant Holder Full Name: KALEO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AUVI-Q (EPINEPHRINE)
EQ 0.15MG/DELIVERY Marketing Status: Prescription

Active Ingredient: EPINEPHRINE
Proprietary Name: AUVI-Q
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, SUBCUTANEOUS
Strength: EQ 0.15MG/DELIVERY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: BX
Application Number: N201739
Product Number: 002
Approval Date: Aug 10, 2012
Applicant Holder Full Name: KALEO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AUVI-Q (EPINEPHRINE)
EQ 0.3MG/DELIVERY Marketing Status: Prescription

Active Ingredient: EPINEPHRINE
Proprietary Name: AUVI-Q
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, SUBCUTANEOUS
Strength: EQ 0.3MG/DELIVERY
Reference Listed Drug: Yes
Reference Standard: No
TE Code: BX
Application Number: N201739
Product Number: 001
Approval Date: Aug 10, 2012
Applicant Holder Full Name: KALEO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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