Approvals (Drugs@FDA)

DAPAGLIFLOZIN

AJANTA PHARMA LTD · DAPAGLIFLOZIN

ANDA211482Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA211482
Sponsor name
AJANTA PHARMA LTD
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260406
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      60239
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211482Orig1s000_TAltr.pdf
      Date
      20191004
      Type
      Letter
  2. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260902
    Review priority
    UNKNOWN
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    DAPAGLIFLOZIN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DAPAGLIFLOZIN
      Strength
      5MG
  2. Product number
    002
    Reference drug
    No
    Brand name
    DAPAGLIFLOZIN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DAPAGLIFLOZIN
      Strength
      10MG
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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.