Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075149
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TICLOPIDINE HYDROCHLORIDE TICLOPIDINE HYDROCHLORIDE 250MG TABLET;ORAL Prescription AB No Yes
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 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75149ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/16/2002 SUPPL-4 Labeling

Label is not available on this site.

05/28/2002 SUPPL-3 Labeling

Label is not available on this site.

04/20/2001 SUPPL-2 Labeling

Label is not available on this site.

01/29/2001 SUPPL-1 Labeling

Label is not available on this site.

TICLOPIDINE HYDROCHLORIDE

TABLET;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TICLOPIDINE HYDROCHLORIDE TICLOPIDINE HYDROCHLORIDE 250MG TABLET;ORAL Prescription No AB 075089 APOTEX
TICLOPIDINE HYDROCHLORIDE TICLOPIDINE HYDROCHLORIDE 250MG TABLET;ORAL Prescription No AB 075526 SUN PHARM INDS INC
TICLOPIDINE HYDROCHLORIDE TICLOPIDINE HYDROCHLORIDE 250MG TABLET;ORAL Prescription No AB 075149 TEVA

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