APPLICATION
ANDA211666
TYPE
ANDA
ORIGINAL APPROVAL
2021-02-22
LATEST ACTION
2022-11-09
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Over-the-counter
Products
IBUPROFENOver-the-counter
IBUPROFEN 100MG/5ML · SUSPENSION · ORAL
Approval history
2022-11-09Manufacturing (CMC) · Supplement 2 · unknownAP
2022-11-04Manufacturing (CMC) · Supplement 1 · unknownAP
2021-02-22UNKNOWN · 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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