FDA Orange Book · active-ingredient family
Ticlopidine hydrochloride
Ticlopidine hydrochloride is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TICLID · NDA 019979
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TICLID×2 | ROCHE PALO | NDA 019979 | — | Mar 24, 1993 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TICLOPIDINE HYDROCHLORIDE | SUN PHARM INDS INC | ANDA 075526 | — | Sep 26, 2002 | |
| TICLOPIDINE HYDROCHLORIDE | WATSON LABS | ANDA 075309 | — | Apr 26, 2000 | |
| TICLOPIDINE HYDROCHLORIDE | NATCO PHARMA | ANDA 075316 | — | Nov 02, 1999 | |
| TICLOPIDINE HYDROCHLORIDE | MYLAN | ANDA 075161 | — | Sep 13, 1999 | |
| TICLOPIDINE HYDROCHLORIDE | ACTAVIS ELIZABETH | ANDA 075253 | — | Aug 20, 1999 | |
| TICLOPIDINE HYDROCHLORIDE | CHARTWELL RX | ANDA 075318 | — | Aug 20, 1999 | |
| TICLOPIDINE HYDROCHLORIDE | CHARTWELL RX | ANDA 075326 | — | Aug 20, 1999 | |
| TICLOPIDINE HYDROCHLORIDE | TEVA | ANDA 075149 | — | Aug 20, 1999 | |
| TICLOPIDINE HYDROCHLORIDE | APOTEX | ANDA 075089 | — | Jul 01, 1999 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Ticlopidine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
