Approvals (Drugs@FDA)

TRETINOIN

BARR LABS INC · TRETINOIN

ANDA077684Generic (ANDA)Discontinued
Open FDA's page for this record
Application number
ANDA077684
Sponsor name
BARR LABS INC
Submissions
  1. Submission type
    SUPPL
    Submission number
    14
    Submission status
    AP
    Submission status date
    20250224
    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
    20070621
    Application docs
    1. ID
      9076
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077684s000ltr.pdf
      Date
      20070705
      Type
      Letter
  3. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20090824
    Submission class code
    LABELING
    Submission class code description
    Labeling
  4. Submission type
    SUPPL
    Submission number
    15
    Submission status
    AP
    Submission status date
    20250224
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    TRETINOIN
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      TRETINOIN
      Strength
      10MG
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

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.