APPLICATION
ANDA209207
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-27
LATEST ACTION
2018-08-24
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Over-the-counter
Products
IBUPROFENOver-the-counter
IBUPROFEN 100MG/5ML · SUSPENSION · ORAL
Approval history
2018-08-24Manufacturing (CMC) · Supplement 4 · standardAP
2017-06-27UNKNOWN · 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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