FDA Orange Book · active-ingredient family
Trandolapril
Trandolapril is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MAVIK · NDA 020528
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MAVIKRLD×3 | ABBVIE | NDA 020528 | — | Apr 26, 1996 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRANDOLAPRIL×3 | SENORES PHARMS | ANDA 078493 | — | Aug 25, 2008 | |
| TRANDOLAPRIL×3 | EPIC PHARMA | ANDA 078508 | AB | Jun 18, 2008 | |
| TRANDOLAPRIL×3 | PHARMOBEDIENT | ANDA 078346 | — | Apr 28, 2008 | |
| TRANDOLAPRIL×3 | AUROBINDO PHARMA | ANDA 078438 | AB | Jun 12, 2007 | |
| TRANDOLAPRIL×3 | CHARTWELL MOLECULAR | ANDA 077307 | — | Jun 12, 2007 | |
| TRANDOLAPRIL×3 | EPIC PHARMA LLC | ANDA 077256 | — | Jun 12, 2007 | |
| TRANDOLAPRIL×3 | INVAGEN PHARMS | ANDA 078320 | — | Jun 12, 2007 | |
| TRANDOLAPRIL×3 | LUPIN | ANDA 077522 | AB | Jun 12, 2007 | |
| TRANDOLAPRIL×3 | WATSON LABS | ANDA 077805 | — | Jun 12, 2007 | |
| TRANDOLAPRIL×3 | TEVA PHARMS | ANDA 077489 | — | Dec 12, 2006 |
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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
