Viewing data from:

TICLOPIDINE HYDROCHLORIDE

ANDA

TICLOPIDINE HYDROCHLORIDE | A075089 | APOTEX INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain2 active DMFs5 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLTICLOPIDINE HYDROCHLORIDE

DMF 104921993

CURIA ITALY SRLTICLOPIDINE HYDROCHLORIDE

DMF 126431997

ORGAMOL SAInactiveTICLOPIDINE

DMF 35991979

SANOFI SYNTHELABO INCInactiveTICLOPIDINE HYDROCHLORIDE

DMF 79751989

SANOFI SYNTHELABO INCInactiveTICLOPIDINE HYDROCHLORIDE

DMF 96381992

ERREGIERRE SPAInactiveTICLOPIDINE HYDROCHLORIDE

DMF 119681996

AARTI DRUGS LTDInactiveTICLOPIDINE HYDROCHLORIDE

DMF 223552008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 1, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 1, 1999

No patent or exclusivity listings for this strength.