Approvals (Drugs@FDA)

FEXOFENADINE HYDROCHLORIDE

CONTRACT PHARMACAL · FEXOFENADINE HYDROCHLORIDE

ANDA219032Generic (ANDA)Over-the-counter
Open FDA's page for this record
Application number
ANDA219032
Sponsor name
CONTRACT PHARMACAL
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250228
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    FEXOFENADINE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Over-the-counter
    Active ingredients
    1. Name
      FEXOFENADINE HYDROCHLORIDE
      Strength
      60MG
  2. Product number
    002
    Reference drug
    No
    Brand name
    FEXOFENADINE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Over-the-counter
    Active ingredients
    1. Name
      FEXOFENADINE HYDROCHLORIDE
      Strength
      180MG
Harmonized identifiers (openFDA)
Application number
ANDA219032
Brand name
FEXOFENADINE
Generic name
FEXOFENADINE
Manufacturer name
YYBA Corp
Product NDC
73581-012
Product type
HUMAN OTC DRUG
Route
ORAL
Substance name
FEXOFENADINE HYDROCHLORIDE
RxCUI
997501
SPL ID
579c7ff9-0c45-1d46-e063-6294a90aef34
SPL set ID
579c7ff9-0c44-1d46-e063-6294a90aef34
Package NDC
73581-012-01, 73581-012-06, 73581-012-02
UNII
2S068B75ZU
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.