Approvals (Drugs@FDA)

DAPAGLIFLOZIN

AIZANT · DAPAGLIFLOZIN

ANDA211523Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA211523
Sponsor name
AIZANT
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
      60241
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211523Orig1s000TA_ltr.pdf
      Date
      20230428
      Type
      Letter
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
ANDA211523
Brand name
DAPAGLIFLOZIN
Generic name
DAPAGLIFLOZIN
Manufacturer name
Apotex Corp.
Product NDC
60505-4911, 60505-4912
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
DAPAGLIFLOZIN
RxCUI
1488569, 1488574
SPL ID
4f19d2f5-0d0c-0e1b-e063-6394a90a2898
SPL set ID
bd9766c5-104f-4636-897d-b6c92eb94f18
Package NDC
60505-4911-3, 60505-4912-3
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.