APPLICATION
ANDA211544
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-16
LATEST ACTION
2024-01-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter
Products
ACETAMINOPHENOver-the-counter
ACETAMINOPHEN 650MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-01-18Labeling · Supplement 16 · standardAP
2019-04-16UNKNOWN · 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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