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FDA ANDA · ANDA214036

TRIFLURIDINE; TIPIRACIL

Sponsor: INTAS PHARMS LTD

APPLICATION
ANDA214036
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

TRIFLURIDINE; TIPIRACILNone (Tentative Approval)
TRIFLURIDINE 15MG/6.14MG, TIPIRACIL · TABLET · ORAL
TRIFLURIDINE; TIPIRACILNone (Tentative Approval)
TRIFLURIDINE 20MG/8.19MG, TIPIRACIL · TABLET · ORAL

Approval history

2022-10-13UNKNOWN · Original · standardLetterTA
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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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