Approvals (Drugs@FDA)

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

MSN · DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE

ANDA211479Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA211479
Sponsor name
MSN
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
      63420
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211479Orig1s000TAltr.pdf
      Date
      20200604
      Type
      Letter
Products
  1. 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
      500MG
  2. 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
      500MG
  3. Product number
    004
    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
  4. 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
      5MG
    2. Name
      METFORMIN HYDROCHLORIDE
      Strength
      1GM
Harmonized identifiers (openFDA)
Application number
ANDA211479
Brand name
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Generic name
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Manufacturer name
Novadoz Pharmaceuticals LLC
Product NDC
72205-434, 72205-435, 72205-436, 72205-437
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
RxCUI
1593058, 1593068, 1593070, 1593072
SPL ID
4f890458-be94-4baf-b606-83a097e1e23e
SPL set ID
4f890458-be94-4baf-b606-83a097e1e23e
Package NDC
72205-434-01, 72205-434-02, 72205-435-01, 72205-435-03, 72205-435-02, 72205-436-01, 72205-436-02, 72205-437-01, 72205-437-03, 72205-437-02
Nui
N0000187059, N0000187058
Pharm class epc
Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
Pharm class moa
Sodium-Glucose Transporter 2 Inhibitors [MoA]
UNII
1ULL0QJ8UC, 786Z46389E
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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.