Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075326
Company: YAOPHARMA CO LTD
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/anda/99/75-326_Ticlopidine%20Hydrochloride_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75326ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-326_Ticlopidine.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/19/2002 SUPPL-4 Labeling

Label is not available on this site.

10/04/2000 SUPPL-3 Labeling

Label is not available on this site.

02/10/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/2000 SUPPL-1 Manufacturing (CMC)-Facility

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/anda/99/75-326_Ticlopidine%20Hydrochloride_prntlbl.pdf

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