Approvals (Drugs@FDA)

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

KNACK · LEVOFLOXACIN

ANDA216164Generic (ANDA)Discontinued
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Application number
ANDA216164
Sponsor name
KNACK
Submissions
  1. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240920
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240129
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Discontinued
    Te code
    AP
    Active ingredients
    1. Name
      LEVOFLOXACIN
      Strength
      EQ 500MG/100ML (EQ 5MG/ML)
  2. Product number
    003
    Reference drug
    No
    Brand name
    LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Discontinued
    Te code
    AP
    Active ingredients
    1. Name
      LEVOFLOXACIN
      Strength
      EQ 750MG/150ML (EQ 5MG/ML)
  3. Product number
    001
    Reference drug
    No
    Brand name
    LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Discontinued
    Te code
    AP
    Active ingredients
    1. Name
      LEVOFLOXACIN
      Strength
      EQ 250MG/50ML (EQ 5MG/ML)
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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.