APPLICATION
ANDA218854
TYPE
ANDA
ORIGINAL APPROVAL
2025-12-29
LATEST ACTION
2025-12-29
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter
Products
PSEUDOEPHEDRINE HYDROCHLORIDEOver-the-counter
PSEUDOEPHEDRINE HYDROCHLORIDE 240MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
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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