Approvals (Drugs@FDA)

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

SUN PHARM · DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE

ANDA211491Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA211491
Sponsor name
SUN PHARM
Submissions
  1. Submission type
    ORIG
    Submission number
    2
    Submission status
    TA
    Submission status date
    20260406
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260406
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      60240
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211491Orig1s000_TAltr.pdf
      Date
      20191004
      Type
      Letter
  3. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260521
    Review priority
    UNKNOWN
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DAPAGLIFLOZIN
      Strength
      10MG
    2. Name
      METFORMIN HYDROCHLORIDE
      Strength
      500MG
  2. Product number
    003
    Reference drug
    No
    Brand name
    DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DAPAGLIFLOZIN
      Strength
      10MG
    2. Name
      METFORMIN HYDROCHLORIDE
      Strength
      1GM
  3. Product number
    001
    Reference drug
    No
    Brand name
    DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DAPAGLIFLOZIN
      Strength
      5MG
    2. Name
      METFORMIN HYDROCHLORIDE
      Strength
      1GM
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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.