Approvals (Drugs@FDA)

TOFACITINIB CITRATE

SCIEGEN PHARMS · TOFACITINIB CITRATE

ANDA220972Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA220972
Sponsor name
SCIEGEN PHARMS
Submissions
  1. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20261008
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260625
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  3. 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
  4. Submission type
    ORIG
    Submission number
    2
    Submission status
    AP
    Submission status date
    20261106
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. 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
  2. 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
ANDA220972
Brand name
TOFACITINIB CITRATE
Generic name
TOFACITINIB CITRATE
Manufacturer name
ScieGen Pharmaceuticals, INC., Radha Pharmaceuticals, Inc.
Product NDC
50228-567, 77771-567
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
TOFACITINIB CITRATE
RxCUI
1741046
SPL ID
1be25def-3272-4a8f-b320-7001581feadf, 12039792-2d83-46ac-be82-fdbd00191024
SPL set ID
11d08738-efa3-4474-8eda-812bc04adfbb, 141ab3eb-982b-4242-89db-6ddce5be0c40
Package NDC
50228-567-30, 50228-567-10, 77771-567-30
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.