Orange Book product · Brand (NDA)
ZEBETA
BISOPROLOL FUMARATE
At a glance
Jul 31, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 31, 1992
34 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
BISOPROLOL FUMARATE
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 019982
Product number
002
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.
- 2026BISOPROLOL FUMARATEGeneric (ANDA)
ANDA 218303 · MICRO LABS
- 2025BISOPROLOL FUMARATEGeneric (ANDA)
ANDA 219044 · UNIQUE PHARM
- 2025BISOPROLOL FUMARATEGeneric (ANDA)
ANDA 075643 · RUBICON RESEARCH
- 2024BISOPROLOL FUMARATEGeneric (ANDA)
ANDA 217617 · HARMAN FINOCHEM
- 2023BISOPROLOL FUMARATEGeneric (ANDA)
ANDA 217368 · PRINSTON INC
- 2022BISOPROLOL FUMARATEGeneric (ANDA)
ANDA 215680 · ZYDUS LIFESCIENCES
- 2021BISOPROLOL FUMARATEGeneric (ANDA)
ANDA 215563 · NOVITIUM PHARMA
- 2017BISOPROLOL FUMARATEGeneric (ANDA)
ANDA 204891 · ALEMBIC
- 2009BISOPROLOL FUMARATEGeneric (ANDA)
ANDA 078635 · UNICHEM
- 2006BISOPROLOL FUMARATEGeneric (ANDA)
ANDA 077910 · AUROBINDO PHARMA
- 2005BISOPROLOL FUMARATEGeneric (ANDA)
ANDA 075831 · NATCO PHARMA USA
- 2002BISOPROLOL FUMARATEGeneric (ANDA)
ANDA 075474 · TP ANDA HOLDINGS
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.
