FDA Orange Book · active-ingredient family
Carvedilol
Carvedilol is approved as 1 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COREG · NDA 020297
1
Brand (NDA)
17
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COREGRLD×4 | WAYLIS THERAP | NDA 020297 | AB | May 29, 1997 |
Generic (ANDA) products (17)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CARVEDILOL×4 | MLV | ANDA 078786 | AB | Dec 22, 2009 | |
| CARVEDILOL×4 | PLIVA HRVATSKA DOO | ANDA 078240 | — | Oct 30, 2007 | |
| CARVEDILOL×4 | HIKMA | ANDA 077887 | — | Sep 07, 2007 | |
| CARVEDILOL×4 | AUROBINDO PHARMA | ANDA 078332 | AB | Sep 05, 2007 | |
| CARVEDILOL×4 | CHARTWELL MOLECULAR | ANDA 077474 | AB | Sep 05, 2007 | |
| CARVEDILOL×4 | GLENMARK PHARMS LTD | ANDA 078251 | AB | Sep 05, 2007 | |
| CARVEDILOL×4 | LUPIN | ANDA 078217 | — | Sep 05, 2007 | |
| CARVEDILOL×4 | PHARMOBEDIENT | ANDA 077316 | — | Sep 05, 2007 | |
| CARVEDILOL×4 | REGCON HOLDINGS | ANDA 078384 | AB | Sep 05, 2007 | |
| CARVEDILOL×4 | RISING | ANDA 076649 | AB | Sep 05, 2007 | |
| CARVEDILOL×4 | RUBICON RESEARCH | ANDA 078165 | AB | Sep 05, 2007 | |
| CARVEDILOL×4 | SANDOZ | ANDA 078227 | AB | Sep 05, 2007 | |
| CARVEDILOL×4 | SUN PHARM INDS INC | ANDA 077346 | — | Sep 05, 2007 | |
| CARVEDILOL×4 | SUN PHARM INDS LTD | ANDA 076989 | — | Sep 05, 2007 | |
| CARVEDILOL×4 | TARO | ANDA 077780 | — | Sep 05, 2007 | |
| CARVEDILOL×4 | TEVA | ANDA 076373 | AB | Sep 05, 2007 | |
| CARVEDILOL×4 | ZYDUS PHARMS USA INC | ANDA 077614 | AB | Sep 05, 2007 |
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.
Carvedilol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
