Approvals (Drugs@FDA)

DAPAGLIFLOZIN

INVENTIA · DAPAGLIFLOZIN

ANDA211156Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA211156
Sponsor name
INVENTIA
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
      59123
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/211156Orig1s000Panoramaltr.pdf
      Date
      20260609
      Type
      Letter
  2. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20260528
    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
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DAPAGLIFLOZIN
      Strength
      10MG
  2. 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
Harmonized identifiers (openFDA)
Application number
ANDA211156
Brand name
DAPAGLIFLOZIN
Generic name
DAPAGLIFLOZIN
Manufacturer name
Florida Pharmaceutical Products, LLC, ANI Pharmaceuticals, Inc.
Product NDC
71921-420, 71921-421, 70954-856, 70954-857
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
DAPAGLIFLOZIN
RxCUI
1488569, 1488574
SPL ID
556192c0-e928-2fe6-e063-6394a90a9312, 9f090435-dd9f-4eda-9551-bcafafc16c5b
SPL set ID
20a83ea2-6ad8-4bbb-b516-73c0a9e37399, 6425d240-5dd9-4a2c-9348-f8a859702850
Package NDC
71921-420-33, 71921-420-09, 71921-420-50, 71921-421-33, 71921-421-09, 71921-421-50, 70954-856-10, 70954-857-10
Nui
N0000187059, N0000187058
Pharm class epc
Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
Pharm class moa
Sodium-Glucose Transporter 2 Inhibitors [MoA]
UNII
1ULL0QJ8UC
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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.