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Approvals (Drugs@FDA)

TOFACITINIB CITRATE

AJANTA PHARMA LTD · TOFACITINIB CITRATE

ANDA219542Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA219542
Sponsor name
AJANTA PHARMA LTD
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250819
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20261008
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    ORIG
    Submission number
    2
    Submission status
    AP
    Submission status date
    20261019
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  4. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20261008
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
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
  2. Product number
    002
    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 22MG BASE
Harmonized identifiers (openFDA)
Application number
ANDA219542
Brand name
TOFACITINIB
Generic name
TOFACITINIB
Manufacturer name
Ajanta Pharma USA Inc.
Product NDC
27241-270
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
TOFACITINIB CITRATE
RxCUI
1741046
SPL ID
c2a18bfc-c6a0-482a-b3e9-df80acb9e36c
SPL set ID
024bb9f2-8c26-4d9d-a33b-eb3c0a7c59ed
Package NDC
27241-270-30
UNII
O1FF4DIV0D
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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.