Orange Book product · Brand (NDA)
LOTENSIN HCT
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
At a glance
May 19, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 19, 1992
34 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Strength
5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 020033
Product number
001
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.
- 2014BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 078794 · APOTEX
- 2005BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 077483 · SUN PHARM INDS LTD
- 2004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 076342 · ANI PHARMS
- 2004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 076348 · ANI PHARMS
- 2004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 076688 · AUROBINDO PHARMA USA
- 2004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 076612 · MYLAN PHARMS INC
- 2004BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 076631 · 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.
