Orange Book product · Generic (ANDA)
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
At a glance
Jul 25, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 25, 2025
11 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Strength
12.5MG;20MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 209199
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
- 2003BENICAR HCTBrand (NDA)
NDA 021532 · COSETTE
- 2026OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 206371 · MICRO LABS
- 2026OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 208465 · SCIEGEN PHARMS
- 2025OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 217398 · MSN
- 2025OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 214427 · HANGZHOU BINJIANG
- 2024OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 207037 · ALKEM LABS LTD
- 2023OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 204801 · MACLEODS PHARMS LTD
- 2023OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 206377 · ZYDUS PHARMS
- 2019OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 208847 · UMEDICA
- 2019OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 209281 · ACCORD HLTHCARE
- 2017OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 206515 · TORRENT
- 2017OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 204233 · ALEMBIC
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.
