Orange Book product · Brand (NDA)
COREG
CARVEDILOL
At a glance
May 29, 1997
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 29, 1997
29 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
CARVEDILOL
Strength
3.125MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020297
Product number
004
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2009CARVEDILOLGeneric (ANDA)
ANDA 078786 · MLV
- 2007CARVEDILOLGeneric (ANDA)
ANDA 078240 · PLIVA HRVATSKA DOO
- 2007CARVEDILOLGeneric (ANDA)
ANDA 077887 · HIKMA
- 2007CARVEDILOLGeneric (ANDA)
ANDA 078332 · AUROBINDO PHARMA
- 2007CARVEDILOLGeneric (ANDA)
ANDA 077474 · CHARTWELL MOLECULAR
- 2007CARVEDILOLGeneric (ANDA)
ANDA 078251 · GLENMARK PHARMS LTD
- 2007CARVEDILOLGeneric (ANDA)
ANDA 078217 · LUPIN
- 2007CARVEDILOLGeneric (ANDA)
ANDA 077316 · PHARMOBEDIENT
- 2007CARVEDILOLGeneric (ANDA)
ANDA 078384 · REGCON HOLDINGS
- 2007CARVEDILOLGeneric (ANDA)
ANDA 076649 · RISING
- 2007CARVEDILOLGeneric (ANDA)
ANDA 078165 · RUBICON RESEARCH
- 2007CARVEDILOLGeneric (ANDA)
ANDA 078227 · SANDOZ
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.
