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FDA ANDA · ANDA212943

TOFACITINIB CITRATE

Sponsor: AJANTA PHARMA LTD

APPLICATION
ANDA212943
TYPE
ANDA
ORIGINAL APPROVAL
2021-06-01
LATEST ACTION
2026-03-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TOFACITINIB CITRATEPrescription
TOFACITINIB CITRATE EQ 10MG BASE · TABLET · ORAL

Approval history

2026-03-20UNKNOWN · Original · standard — Letter ↗AP
2026-02-18Labeling · Supplement 4 · standardAP
2026-02-18Labeling · Supplement 7 · standardAP
2026-02-18Labeling · Supplement 5 · standardAP
2026-02-18Labeling · Supplement 1 · standardAP
2026-02-18Labeling · Supplement 6 · standardAP
2021-06-01UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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