Approvals (Drugs@FDA)

VOBRIG

SUN PHARM · LEUPROLIDE ACETATE

NDA213225Drug (NDA)Discontinued
Open FDA's page for this record
Application number
NDA213225
Sponsor name
SUN PHARM
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260826
    Review priority
    STANDARD
    Submission class code
    TYPE 5
    Submission class code description
    Type 5 - New Formulation or New Manufacturer
    Application docs
    1. ID
      87058
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213225Orig1s000ltr.pdf
      Date
      20260828
      Type
      Letter
    2. ID
      87092
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213225Orig1s000lbl.pdf
      Date
      20260901
      Type
      Label
    3. ID
      87093
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213225Orig1s000lbl.pdf#page=12
      Date
      20260901
      Type
      Medication Guide
Products
  1. Product number
    001
    Reference drug
    Yes
    Brand name
    VOBRIG
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      LEUPROLIDE ACETATE
      Strength
      28MG/2.8ML (10MG/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.