Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075089
Company: APOTEX

Products on ANDA 075089

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TICLOPIDINE HYDROCHLORIDE	TICLOPIDINE HYDROCHLORIDE	250MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075089

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/01/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75089ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2001	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
11/21/2001	SUPPL-6	Manufacturing (CMC)-Formulation		Label is not available on this site.
11/21/2001	SUPPL-5	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
07/05/2002	SUPPL-4	Labeling		Label is not available on this site.
01/27/2000	SUPPL-3	Labeling		Label is not available on this site.
07/11/2000	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/11/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075089

TICLOPIDINE HYDROCHLORIDE

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TICLOPIDINE HYDROCHLORIDE	TICLOPIDINE HYDROCHLORIDE	250MG	TABLET;ORAL	Prescription	No	AB	075089	APOTEX