APPLICATION
ANDA210762
TYPE
ANDA
ORIGINAL APPROVAL
2019-05-03
LATEST ACTION
2025-04-24
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FENTANYL CITRATE PRESERVATIVE FREEPrescription
FENTANYL CITRATE EQ 0.05MG BASE/ML · INJECTABLE · INJECTION
Approval history
2025-04-24Labeling · Supplement 8 · standardAP
2025-04-24Labeling · Supplement 6 · standardAP
2025-04-24Labeling · Supplement 7 · standardAP
2020-05-07Labeling · Supplement 1 · 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.
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