FDA Orange Book · active-ingredient family
Perindopril erbumine
Perindopril erbumine is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ACEON · NDA 020184
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACEONRLD×3 | SYMPLMED PHARMS LLC | NDA 020184 | — | Dec 30, 1993 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PERINDOPRIL ERBUMINE×3 | APOTEX | ANDA 090463 | — | Aug 30, 2010 | |
| PERINDOPRIL ERBUMINE×3 | LUPIN LTD | ANDA 078263 | — | Jan 27, 2010 | |
| PERINDOPRIL ERBUMINE×3 | ANI PHARMS | ANDA 078138 | — | Nov 10, 2009 | |
| PERINDOPRIL ERBUMINE×3 | AUROBINDO PHARMA | ANDA 079070 | — | Nov 10, 2009 | |
| PERINDOPRIL ERBUMINE×3 | HIKMA | ANDA 090072 | — | Nov 10, 2009 |
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.
Perindopril erbumine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
