FDA Orange Book · active-ingredient family
Nadolol
Nadolol is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CORGARD · NDA 018063
1
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CORGARDRLD×5 | USWM | NDA 018063 | — | Oct 28, 1986 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NADOLOL×3 | ALEMBIC | ANDA 211763 | AB | Jun 02, 2023 | |
| NADOLOL×3 | AUROBINDO PHARMA | ANDA 201893 | AB | Jun 07, 2022 | |
| NADOLOL×3 | RK PHARMA | ANDA 212856 | AB | Sep 13, 2019 | |
| NADOLOL×3 | REGCON HOLDINGS | ANDA 210955 | AB | Jul 23, 2018 | |
| NADOLOL×3 | INGENUS PHARMS LLC | ANDA 210786 | — | Jun 01, 2018 | |
| NADOLOL×3 | CHARTWELL RX | ANDA 209309 | AB | Oct 05, 2017 | |
| NADOLOL×3 | ZYDUS PHARMS | ANDA 207761 | AB | Jul 28, 2017 | |
| NADOLOL×3 | AMNEAL PHARMS CO | ANDA 208832 | AB | Jun 02, 2017 | |
| NADOLOL×3 | INVAGEN PHARMS | ANDA 203455 | AB | Dec 18, 2015 | |
| NADOLOL×2 | HERITAGE PHARMA | ANDA 074229 | — | Aug 30, 1996 | |
| NADOLOL×3 | HERITAGE PHARMA | ANDA 074255 | — | Jan 24, 1996 | |
| NADOLOL×3 | SANDOZ | ANDA 074501 | AB | Nov 09, 1995 | |
| NADOLOL×3 | TEVA PHARMS | ANDA 074368 | — | Aug 31, 1994 | |
| NADOLOL×3 | RISING | ANDA 074172 | AB | Oct 31, 1993 |
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.
Nadolol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
