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FDA ANDA · ANDA212971
ALLERGY RELIEF
fexofenadine hydrochloride
Sponsor: L PERRIGO CO
APPLICATION
ANDA212971
TYPE
ANDA
ORIGINAL APPROVAL
2020-02-24
LATEST ACTION
2022-11-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
FEXOFENADINE HYDROCHLORIDEOver-the-counter
FEXOFENADINE HYDROCHLORIDE 180MG · TABLET · ORAL
FEXOFENADINE HYDROCHLORIDEOver-the-counter
FEXOFENADINE HYDROCHLORIDE 60MG · TABLET · ORAL
Approval history
2022-11-04Manufacturing (CMC) · Supplement 14AP
2022-07-08Manufacturing (CMC) · Supplement 9 · unknownAP
2020-02-24UNKNOWN · 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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