APPLICATION
ANDA215311
TYPE
ANDA
ORIGINAL APPROVAL
2022-05-27
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
IBUPROFENPrescription
IBUPROFEN 100MG/5ML · SUSPENSION · ORAL
Approval history
2024-11-21Labeling · Supplement 5 · standardAP
2024-11-19Labeling · Supplement 3 · standardAP
2024-09-03Manufacturing (CMC) · Supplement 1 · unknownAP
2022-05-27UNKNOWN · Original · 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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