← FDA DRUG APPROVALS
FDA ANDA · ANDA218359
ACETAMINOPHEN AND IBUPROFEN BACK PAIN
acetaminophen and ibuprofen
Sponsor: AUROBINDO PHARMA LTD
APPLICATION
ANDA218359
TYPE
ANDA
ORIGINAL APPROVAL
2024-03-26
LATEST ACTION
2026-06-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
ACETAMINOPHEN AND IBUPROFENOver-the-counter
ACETAMINOPHEN 250MG, IBUPROFEN 125MG · TABLET · ORAL
Approval history
2026-06-10Labeling · Supplement 2 · standardAP
2026-06-10Labeling · Supplement 1 · standardAP
2024-03-26UNKNOWN · 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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