Approvals (Drugs@FDA)

DAPAGLIFLOZIN

CIPLA · DAPAGLIFLOZIN

ANDA211535Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA211535
Sponsor name
CIPLA
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
ANDA211535
Brand name
DAPAGLIFLOZIN
Generic name
DAPAGLIFLOZIN
Manufacturer name
Cipla USA Inc.
Product NDC
69097-388, 69097-389
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
DAPAGLIFLOZIN PROPANEDIOL
RxCUI
1488569, 1488574
SPL ID
a425ceed-bb59-48bb-be43-cf47dbe21fef
SPL set ID
a2f86c0a-ce78-4d06-b5d8-ed457c8e3614
Package NDC
69097-388-02, 69097-389-02
UNII
887K2391VH
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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.