FDA Orange Book · active-ingredient family
Trandolapril; verapamil hydrochloride
Trandolapril; verapamil hydrochloride is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TARKA · NDA 020591
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TARKARLD×4 | ABBVIE | NDA 020591 | — | Oct 22, 1996 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE×4 | GLENMARK PHARMS LTD | ANDA 079135 | — | Aug 30, 2010 |
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.
Trandolapril; verapamil hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
