Approvals (Drugs@FDA)

DASATINIB

DR REDDYS · DASATINIB

ANDA213383Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA213383
Sponsor name
DR REDDYS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250303
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      69656
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213383Orig1s000TAltr.pdf
      Date
      20211220
      Type
      Letter
  2. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20250930
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    006
    Reference drug
    No
    Brand name
    DASATINIB
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DASATINIB
      Strength
      140MG
  2. Product number
    004
    Reference drug
    No
    Brand name
    DASATINIB
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DASATINIB
      Strength
      80MG
  3. Product number
    002
    Reference drug
    No
    Brand name
    DASATINIB
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DASATINIB
      Strength
      50MG
  4. Product number
    005
    Reference drug
    No
    Brand name
    DASATINIB
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DASATINIB
      Strength
      100MG
  5. Product number
    003
    Reference drug
    No
    Brand name
    DASATINIB
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DASATINIB
      Strength
      70MG
  6. Product number
    001
    Reference drug
    No
    Brand name
    DASATINIB
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DASATINIB
      Strength
      20MG
Harmonized identifiers (openFDA)
Application number
ANDA213383
Brand name
DASATINIB
Generic name
DASATINIB
Manufacturer name
Dr.Reddys Laboratories Inc
Product NDC
43598-599, 43598-600, 43598-601, 43598-602, 43598-603, 43598-604
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
DASATINIB
RxCUI
643105, 643107, 643109, 799047, 1045402, 1045406
SPL ID
ce9ef276-e0b1-4bd7-1e16-06035ef595a8
SPL set ID
eb5ddff2-6521-b461-43ac-80ff8660b20b
Package NDC
43598-599-60, 43598-600-60, 43598-601-60, 43598-602-30, 43598-603-30, 43598-604-30
UNII
RBZ1571X5H
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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.