Approvals (Drugs@FDA)

TESTOSTERONE

ACTAVIS LABS UT INC · TESTOSTERONE

ANDA204571Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA204571
Sponsor name
ACTAVIS LABS UT INC
Submissions
  1. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    20190621
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20190621
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    SUPPL
    Submission number
    11
    Submission status
    AP
    Submission status date
    20250715
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  4. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20250630
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  5. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20150805
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      10357
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204571Orig1s000ltr.pdf
      Date
      20150810
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    TESTOSTERONE
    Reference standard
    Yes
    Dosage form
    GEL, METERED
    Route
    TRANSDERMAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      TESTOSTERONE
      Strength
      10MG/0.5GM ACTUATION
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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.