Approvals (Drugs@FDA)

DAPAGLIFLOZIN

LUPIN · DAPAGLIFLOZIN

ANDA211531Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA211531
Sponsor name
LUPIN
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260406
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
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
ANDA211531
Brand name
DAPAGLIFLOZIN
Generic name
DAPAGLIFLOZIN
Manufacturer name
Lupin Pharmaceuticals, Inc.
Product NDC
70748-105, 70748-106
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
DAPAGLIFLOZIN
RxCUI
1488569, 1488574
SPL ID
89e1cb01-a942-4afd-860c-9c53e8e1fc9f
SPL set ID
08baca21-e39e-4e61-961f-d89432fe8007
Package NDC
70748-105-06, 70748-106-06
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.