Orange Book product · Brand (NDA)
DIAMOX
ACETAZOLAMIDE 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
ACETAZOLAMIDE 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EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 009388
Product number
001
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.
- 2025ACETAZOLAMIDE SODIUMGeneric (ANDA)
ANDA 219775 · GLAND
- 2019ACETAZOLAMIDE SODIUMGeneric (ANDA)
ANDA 206533 · ZYDUS PHARMS
- 2017ACETAZOLAMIDE SODIUMGeneric (ANDA)
ANDA 205358 · PH HEALTH
- 2014ACETAZOLAMIDE SODIUMGeneric (ANDA)
ANDA 202693 · AVET LIFESCIENCES
- 2012ACETAZOLAMIDE SODIUMGeneric (ANDA)
ANDA 200880 · MYLAN ASI
- 2008ACETAZOLAMIDE SODIUMGeneric (ANDA)
ANDA 040784 · XGEN PHARMS
- 1995ACETAZOLAMIDE SODIUMGeneric (ANDA)
ANDA 040108 · HOSPIRA
- 1995ACETAZOLAMIDE SODIUMGeneric (ANDA)
ANDA 040089 · HIKMA
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.
