Orange Book product · Brand (NDA)
DIURIL
CHLOROTHIAZIDE SODIUM
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CHLOROTHIAZIDE SODIUM
Strength
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 011145
Product number
005
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.
- 2024CHLOROTHIAZIDE SODIUMGeneric (ANDA)
ANDA 218630 · GLAND
- 2015CHLOROTHIAZIDE SODIUMGeneric (ANDA)
ANDA 202462 · SAGENT PHARMS INC
- 2014CHLOROTHIAZIDE SODIUMGeneric (ANDA)
ANDA 202493 · RK PHARMA
- 2013CHLOROTHIAZIDE SODIUMGeneric (ANDA)
ANDA 202561 · AM REGENT
- 2011CHLOROTHIAZIDE SODIUMGeneric (ANDA)
ANDA 091546 · SUN PHARM
- 2009CHLOROTHIAZIDE SODIUMGeneric (ANDA)
ANDA 090896 · FRESENIUS KABI USA
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.
