APPLICATION
ANDA218417
TYPE
ANDA
ORIGINAL APPROVAL
2026-04-15
LATEST ACTION
2026-04-15
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter
Products
DEXTROMETHORPHAN POLISTIREXOver-the-counter
DEXTROMETHORPHAN POLISTIREX EQ 30MG HYDROBROMIDE/5ML · SUSPENSION, EXTENDED RELEASE · ORAL
Approval history
2026-04-15UNKNOWN · 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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