Orange Book product · Brand (NDA)
ZIAC
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
At a glance
Mar 26, 1993
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 26, 1993
33 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Strength
2.5MG;6.25MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020186
Product number
003
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.
- 2026BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 219489 · UNIQUE PHARM
- 2026BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 217922 · AUROBINDO PHARMA LTD
- 2022BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 215666 · CADILA
- 2022BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 215995 · GLENMARK PHARMS LTD
- 2021BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 215562 · NOVITIUM PHARMA
- 2020BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 212678 · EDENBRIDGE PHARMS
- 2010BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 079106 · UNICHEM
- 2001BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 075686 · TEVA
- 2000BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 075642 · APOTHECON
- 2000BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 075632 · IVAX SUB TEVA PHARMS
- 2000BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 075672 · ACTAVIS ELIZABETH
- 2000BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 075527 · CHARTWELL RX
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.

