Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019979
Company: ROCHE PALO

Products on NDA 019979

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019979

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.

Labels for NDA 019979

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