Approvals (Drugs@FDA)

PACLITAXEL

ACTAVIS TOTOWA · PACLITAXEL

ANDA090130Generic (ANDA)Prescription
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Application number
ANDA090130
Sponsor name
ACTAVIS TOTOWA
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20091209
  2. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20240127
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20110714
    Submission class code
    LABELING
    Submission class code description
    Labeling
  4. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20111118
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    PACLITAXEL
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      PACLITAXEL
      Strength
      6MG/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.