Approvals (Drugs@FDA)

TOFACITINIB CITRATE

AUROBINDO PHARMA LTD · TOFACITINIB CITRATE

ANDA218462Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218462
Sponsor name
AUROBINDO PHARMA LTD
Submissions
  1. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250214
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20250718
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240603
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    TOFACITINIB CITRATE
    Reference standard
    No
    Dosage form
    TABLET, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      TOFACITINIB CITRATE
      Strength
      EQ 11MG BASE
Harmonized identifiers (openFDA)
Application number
ANDA218462
Brand name
TOFACITINIB
Generic name
TOFACITINIB
Manufacturer name
Aurobindo Pharma Limited
Product NDC
59651-685
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
TOFACITINIB CITRATE
RxCUI
1741046
SPL ID
495ffb70-86d7-4a66-bf77-5ae7776ef9e6
SPL set ID
e54b186f-e42a-4477-939c-8dd331045fbe
Package NDC
59651-685-30
UNII
O1FF4DIV0D
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

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.