Orange Book product · Brand (NDA)
CORGARD
NADOLOL
At a glance
Oct 28, 1986
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 28, 1986
40 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
NADOLOL
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 018063
Product number
005
Marketing status
DISCN
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.
- 2023NADOLOLGeneric (ANDA)
ANDA 211763 · ALEMBIC
- 2022NADOLOLGeneric (ANDA)
ANDA 201893 · AUROBINDO PHARMA
- 2019NADOLOLGeneric (ANDA)
ANDA 212856 · RK PHARMA
- 2018NADOLOLGeneric (ANDA)
ANDA 210955 · REGCON HOLDINGS
- 2018NADOLOLGeneric (ANDA)
ANDA 210786 · INGENUS PHARMS LLC
- 2017NADOLOLGeneric (ANDA)
ANDA 209309 · CHARTWELL RX
- 2017NADOLOLGeneric (ANDA)
ANDA 207761 · ZYDUS PHARMS
- 2017NADOLOLGeneric (ANDA)
ANDA 208832 · AMNEAL PHARMS CO
- 2015NADOLOLGeneric (ANDA)
ANDA 203455 · INVAGEN PHARMS
- 1996NADOLOLGeneric (ANDA)
ANDA 074229 · HERITAGE PHARMA
- 1996NADOLOLGeneric (ANDA)
ANDA 074255 · HERITAGE PHARMA
- 1995NADOLOLGeneric (ANDA)
ANDA 074501 · 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.
