Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019979
Company: ROCHE PALO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TICLID TICLOPIDINE HYDROCHLORIDE 125MG TABLET;ORAL Discontinued None No No
TICLID 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
10/31/1991 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/09/2001 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/14/2000 SUPPL-19 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19979-s019_ticlid.pdf
04/18/2001 SUPPL-18 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-979S018_Ticlid_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19979S18ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-879S018_Ticlid.cfm
07/28/1999 SUPPL-17 Labeling

Label is not available on this site.

02/03/1998 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/21/1997 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/24/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/18/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/25/1995 SUPPL-9 Labeling

Label is not available on this site.

01/25/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/24/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/16/1992 SUPPL-5 Labeling

Label is not available on this site.

12/10/1992 SUPPL-3 Labeling

Label is not available on this site.

05/05/1994 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
04/18/2001 SUPPL-18 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-979S018_Ticlid_prntlbl.pdf

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