← FDA DRUG APPROVALS
FDA ANDA · ANDA216792
RUGBY ALLERGY RELIEF D
fexofenadine hydrochloride, pseudoephedrine hydrochloride
Sponsor: L PERRIGO CO
APPLICATION
ANDA216792
TYPE
ANDA
ORIGINAL APPROVAL
2025-10-07
LATEST ACTION
2025-10-07
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter
Products
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEOver-the-counter
FEXOFENADINE HYDROCHLORIDE 60MG, PSEUDOEPHEDRINE HYDROCHLORIDE 120MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-10-07UNKNOWN · 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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