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FDA ANDA · ANDA075089

TICLOPIDINE HYDROCHLORIDE

Sponsor: APOTEX

APPLICATION
ANDA075089
TYPE
ANDA
ORIGINAL APPROVAL
1999-07-01
LATEST ACTION
2002-07-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TICLOPIDINE HYDROCHLORIDEDiscontinued
TICLOPIDINE HYDROCHLORIDE 250MG · TABLET · ORAL

Approval history

2002-07-05Labeling · Supplement 4AP
2001-12-13Manufacturing (CMC) · Supplement 7AP
2001-11-21Manufacturing (CMC) · Supplement 6AP
2001-11-21Manufacturing (CMC) · Supplement 5AP
2000-07-11Manufacturing (CMC) · Supplement 2AP
2000-07-11Manufacturing (CMC) · Supplement 1AP
2000-01-27Labeling · Supplement 3AP
1999-07-01Original — 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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