Drugs@FDA: FDA Approved Drug Products

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

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
TICLOPIDINE HYDROCHLORIDE TICLOPIDINE HYDROCHLORIDE 250MG TABLET;ORAL Prescription No AB 075149 TEVA

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