Orange Book product · Brand (NDA)
HEMICLOR
CHLORTHALIDONE
At a glance
Mar 17, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 17, 2025
1 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
CHLORTHALIDONE
Strength
12.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 218647
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2024CHLORTHALIDONEGeneric (ANDA)
ANDA 209162 · IPCA LABS LTD
- 2022CHLORTHALIDONEGeneric (ANDA)
ANDA 216262 · ALEMBIC
- 2022CHLORTHALIDONEGeneric (ANDA)
ANDA 215587 · MANKIND PHARMA
- 2022CHLORTHALIDONEGeneric (ANDA)
ANDA 212878 · PHARMOBEDIENT
- 2022CHLORTHALIDONEGeneric (ANDA)
ANDA 212875 · PHARMOBEDIENT
- 2022CHLORTHALIDONEGeneric (ANDA)
ANDA 211320 · INVENTIA
- 2022CHLORTHALIDONEGeneric (ANDA)
ANDA 209068 · SUNNY
- 2020CHLORTHALIDONEGeneric (ANDA)
ANDA 214129 · AJANTA PHARMA LTD
- 2020CHLORTHALIDONEGeneric (ANDA)
ANDA 213412 · ALKEM LABS LTD
- 2019CHLORTHALIDONEGeneric (ANDA)
ANDA 211627 · UNICHEM
- 2019CHLORTHALIDONEGeneric (ANDA)
ANDA 207204 · AMNEAL PHARMS CO
- 2019CHLORTHALIDONEGeneric (ANDA)
ANDA 211063 · 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.
