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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075526

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NDA 075526 describes TICLOPIDINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Apotex, Mylan, Sun Pharm Inds Inc, Teva, Watson Labs, and Yaopharma Co Ltd, and is included in nine NDAs. It is available from two suppliers. Additional details are available on the TICLOPIDINE HYDROCHLORIDE profile page.

The generic ingredient in TICLOPIDINE HYDROCHLORIDE is ticlopidine hydrochloride. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ticlopidine hydrochloride profile page.
Summary for 075526
Tradename:TICLOPIDINE HYDROCHLORIDE
Applicant:Sun Pharm Inds Inc
Ingredient:ticlopidine hydrochloride
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details
Pharmacology for NDA: 075526
Physiological EffectDecreased Platelet Aggregation
Suppliers and Packaging for NDA: 075526
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TICLOPIDINE HYDROCHLORIDE ticlopidine hydrochloride TABLET;ORAL 075526 ANDA Caraco Pharmaceutical Laboratories, Ltd. 57664-327 N 57664-327-06
TICLOPIDINE HYDROCHLORIDE ticlopidine hydrochloride TABLET;ORAL 075526 ANDA Caraco Pharmaceutical Laboratories, Ltd. 57664-327 N 57664-327-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Sep 26, 2002TE:ABRLD:No

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