APPLICATION
ANDA078912
TYPE
ANDA
ORIGINAL APPROVAL
2011-11-23
LATEST ACTION
2025-05-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter
Products
GUAIFENESINOver-the-counter
GUAIFENESIN 600MG · TABLET, EXTENDED RELEASE · ORAL
GUAIFENESINOver-the-counter
GUAIFENESIN 1.2GM · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-05-23Manufacturing (CMC) · Supplement 23 · unknownAP
2025-04-15Manufacturing (CMC) · Supplement 21 · unknownAP
2025-01-13Labeling · Supplement 19 · standardAP
2025-01-13Labeling · Supplement 14 · standardAP
2015-03-12Manufacturing (CMC) · Supplement 1AP
2011-11-23OriginalAP
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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