APPLICATION
ANDA205647
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-03
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
IBUPROFENDiscontinued
IBUPROFEN 100MG/5ML · SUSPENSION · ORAL
Approval history
2024-11-21Labeling · Supplement 9 · standardAP
2021-04-28Labeling · Supplement 8 · standardAP
2019-07-22Labeling · Supplement 1 · standardAP
2016-11-03UNKNOWN · 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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