Approvals (Drugs@FDA)

HYDRALAZINE HYDROCHLORIDE

IVAX SUB TEVA PHARMS · HYDRALAZINE HYDROCHLORIDE

ANDA084469Generic (ANDA)Discontinued
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Application number
ANDA084469
Sponsor name
IVAX SUB TEVA PHARMS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    19760219
  2. Submission type
    SUPPL
    Submission number
    53
    Submission status
    AP
    Submission status date
    19890109
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    HYDRALAZINE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      HYDRALAZINE HYDROCHLORIDE
      Strength
      50MG
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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.