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FDA ANDA · ANDA214264

TOFACITINIB

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA214264
TYPE
ANDA
ORIGINAL APPROVAL
2021-08-19
LATEST ACTION
2021-08-19
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

TOFACITINIB CITRATEPrescription
TOFACITINIB CITRATE EQ 22MG BASE · TABLET, EXTENDED RELEASE · ORAL
TOFACITINIB CITRATEPrescription
TOFACITINIB CITRATE EQ 11MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2021-08-19UNKNOWN · 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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