Approvals (Drugs@FDA)

DAPAGLIFLOZIN

BIOCON PHARMA · DAPAGLIFLOZIN

ANDA211470Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA211470
Sponsor name
BIOCON PHARMA
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
      62169
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211470Orig1s000TAltr.pdf
      Date
      20200317
      Type
      Letter
Products
  1. 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
  2. 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
Harmonized identifiers (openFDA)
Application number
ANDA211470
Brand name
DAPAGLIFLOZIN
Generic name
DAPAGLIFLOZIN
Manufacturer name
Biocon Pharma Inc.
Product NDC
70377-023, 70377-024
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
DAPAGLIFLOZIN 2,3-BUTANEDIOL MONOHYDRATE
RxCUI
1488569, 1488574
SPL ID
f23d20a0-8e57-6f45-e23b-0fffcb2f8652
SPL set ID
828f1004-3647-9a13-8008-c4b3759ecfd0
Package NDC
70377-023-11, 70377-023-12, 70377-024-11, 70377-024-12
UNII
U289305BKG
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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.