← FDA DRUG APPROVALS
FDA ANDA · ANDA209254
GUAIFENESIN EXTENDED RELEASE
guaifenesin
Sponsor: OHM LABS INC
APPLICATION
ANDA209254
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-16
LATEST ACTION
2018-07-16
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
2018-07-16UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.