APPLICATION
ANDA213420
TYPE
ANDA
ORIGINAL APPROVAL
2020-05-08
LATEST ACTION
2022-12-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter
Products
GUAIFENESINOver-the-counter
GUAIFENESIN 1.2GM · TABLET, EXTENDED RELEASE · ORAL
GUAIFENESINOver-the-counter
GUAIFENESIN 600MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-12-09Labeling · Supplement 1 · standardAP
2020-05-08UNKNOWN · 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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