Orange Book product · Brand (NDA)
MICARDIS HCT
HYDROCHLOROTHIAZIDE; TELMISARTAN
At a glance
Nov 17, 2000
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 17, 2000
26 yr ago
Today
Pharmaceutical detail
Active ingredient
HYDROCHLOROTHIAZIDE; TELMISARTAN
Strength
12.5MG;40MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021162
Product number
001
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.
- 2025TELMISARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 218406 · MANKIND PHARMA
- 2019TELMISARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 202544 · GLENMARK PHARMS LTD
- 2017TELMISARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 209028 · PRINSTON INC
- 2017TELMISARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 204221 · ZYDUS PHARMS
- 2016TELMISARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 208727 · AUROBINDO PHARMA
- 2015TELMISARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 204169 · MACLEODS PHARMS LTD
- 2014TELMISARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 091351 · LUPIN
- 2014TELMISARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 203010 · ALEMBIC
- 2014TELMISARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 091648 · NATCO
- 2014TELMISARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 201192 · TORRENT
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.
