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Abbreviated New Drug Application (ANDA): 212943
Company: AJANTA PHARMA LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/20/2026 ORIG-2 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212943Orig2s000TAltr.pdf
06/01/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212943Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/18/2026 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
02/18/2026 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
02/18/2026 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
02/18/2026 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
02/18/2026 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

TOFACITINIB CITRATE

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET;ORAL Prescription No AB 212943 AJANTA PHARMA LTD
TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET;ORAL Prescription No AB 218096 APOTEX
TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET;ORAL Prescription No AB 215356 AUROBINDO PHARMA LTD
TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET;ORAL Prescription No AB 209633 BRECKENRIDGE
TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET;ORAL Prescription No AB 218821 CONCORD BIOTECH LTD
TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET;ORAL Prescription No AB 219530 MACLEODS PHARMS LTD
TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET;ORAL Prescription No AB 209738 MICRO LABS
TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET;ORAL Prescription No AB 217299 MSN
TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET;ORAL Prescription No AB 220137 SOMERSET THERAPS LLC
TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET;ORAL Prescription No AB 219395 SPECGX LLC
TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET;ORAL Prescription No AB 215552 YAOPHARMA CO LTD
TOFACITINIB CITRATE TOFACITINIB CITRATE EQ 10MG BASE TABLET;ORAL Prescription No AB 209829 ZYDUS PHARMS
XELJANZ TOFACITINIB CITRATE EQ 10MG BASE TABLET;ORAL Prescription Yes AB 203214 PF PRISM CV
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