Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075161
Company: MYLAN

Products on ANDA 075161

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075161

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75161_Ticlopidine%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75161ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075161_ticlopidine_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2002	SUPPL-5	Labeling		Label is not available on this site.
03/13/2002	SUPPL-4	Labeling		Label is not available on this site.
05/30/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
01/03/2001	SUPPL-2	Labeling		Label is not available on this site.
11/06/2000	SUPPL-1	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.

Labels for ANDA 075161

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/13/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75161_Ticlopidine%20Hydrochloride_Prntlbl.pdf