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FDA ANDA · ANDA204507

FEXOFENADINE HCL

Sponsor: SCIEGEN PHARMS

APPLICATION
ANDA204507
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-16
LATEST ACTION
2015-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

FEXOFENADINE HYDROCHLORIDE HIVESOver-the-counter
FEXOFENADINE HYDROCHLORIDE 60MG · TABLET · ORAL
FEXOFENADINE HYDROCHLORIDE ALLERGYOver-the-counter
FEXOFENADINE HYDROCHLORIDE 60MG · TABLET · ORAL
FEXOFENADINE HYDROCHLORIDE HIVESOver-the-counter
FEXOFENADINE HYDROCHLORIDE 180MG · TABLET · ORAL
FEXOFENADINE HYDROCHLORIDE ALLERGYOver-the-counter
FEXOFENADINE HYDROCHLORIDE 180MG · TABLET · ORAL

Approval history

2015-09-16UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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