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FDA NDA · NDA201739

AUVI-Q

epinephrine

Sponsor: KALEO INC

APPLICATION
NDA201739
TYPE
NDA
ORIGINAL APPROVAL
2012-08-10
LATEST ACTION
2025-04-30
ROUTE
INTRAMUSCULAR, INTRAMUSCULAR, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

AUVI-Q · ReferencePrescription
EPINEPHRINE EQ 0.3MG/DELIVERY · SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS
AUVI-Q · ReferencePrescription
EPINEPHRINE EQ 0.15MG/DELIVERY · SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS
AUVI-Q · ReferencePrescription
EPINEPHRINE EQ 0.1MG/DELIVERY · SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS

Approval history

2025-04-30Labeling · Supplement 30 · standard — Letter ↗AP
2024-02-28Labeling · Supplement 28 · standard — Letter ↗AP
2019-09-28Labeling · Supplement 15 · standard — Letter ↗AP
2017-11-17Labeling · Supplement 9 · standard — Label ↗AP
2017-11-17Efficacy · Supplement 8 · priority — Label ↗AP
2017-02-17UNKNOWN · Supplement 6 · standard — Letter ↗AP
2016-12-19Manufacturing (CMC) · Supplement 7 · standardAP
2016-05-18Labeling · Supplement 4 · 901 required — Label ↗AP
2015-04-22Manufacturing (CMC) · Supplement 3 · standardAP
2014-03-22Manufacturing (CMC) · Supplement 2 · standardAP
2012-08-10Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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