APPLICATION
ANDA090589
TYPE
ANDA
ORIGINAL APPROVAL
2018-08-16
LATEST ACTION
2021-04-23
ROUTE
INTRAMUSCULAR, SUBCUTANEOUS, INTRAMUSCULAR, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
EPINEPHRINE (AUTOINJECTOR)Prescription
EPINEPHRINE 0.15MG/DELIVERY · INJECTABLE · INTRAMUSCULAR, SUBCUTANEOUS
EPINEPHRINE (AUTOINJECTOR)Prescription
EPINEPHRINE 0.3MG/DELIVERY · INJECTABLE · INTRAMUSCULAR, SUBCUTANEOUS
Approval history
2021-04-23Labeling · Supplement 13 · standardAP
2021-04-23Labeling · Supplement 11 · standardAP
2020-05-15Labeling · Supplement 7 · standardAP
2019-09-18Labeling · Supplement 4 · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.