Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075253
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TICLOPIDINE HYDROCHLORIDE TICLOPIDINE HYDROCHLORIDE 250MG TABLET;ORAL Discontinued None 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
08/20/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75-253_Ticlopidine_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75253ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75-253_Ticlopidine.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/05/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/2002 SUPPL-6 Labeling

Label is not available on this site.

11/13/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/2001 SUPPL-2 Labeling

Label is not available on this site.

11/09/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/20/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/75-253_Ticlopidine_prntlbl.pdf

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