Orange Book product · Generic (ANDA)
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
At a glance
Sep 19, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 19, 2024
1 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCHLOROTHIAZIDE
Strength
12.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 083177
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HYDROCHLOROTHIAZIDE
- 2025INZIRQOBrand (NDA)
NDA 219141 · NOVITIUM PHARMA
- 1996MICROZIDEBrand (NDA)
NDA 020504 · TEVA BRANDED PHARM
- —ESIDRIXBrand (NDA)
NDA 011793 · NOVARTIS
- 2023HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 085182 · HERITAGE
- 2019HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 203561 · SCIEGEN PHARMS
- 2014HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 090651 · SUN PHARM INDS INC
- 2012HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 202556 · ACCORD HLTHCARE
- 2012HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 091662 · CHARTWELL MOLECULAR
- 2010HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 200645 · ALEMBIC PHARMS LTD
- 2010HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 090510 · UNICHEM
- 2009HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 079237 · IPCA LABS LTD
- 2008HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 078389 · APOTEX
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.

