Orange Book product · Brand (NDA)
TRUSOPT
DORZOLAMIDE HYDROCHLORIDE
At a glance
Dec 09, 1994
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 09, 1994
32 yr ago
Today
Pharmaceutical detail
Active ingredient
DORZOLAMIDE HYDROCHLORIDE
Strength
EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 020408
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.
- 2025DORZOLAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 215004 · SOMERSET THERAPS LLC
- 2022DORZOLAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 215660 · GLAND
- 2019DORZOLAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 204778 · MICRO LABS
- 2019DORZOLAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 212639 · ALEMBIC
- 2019DORZOLAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 205294 · FDC LTD
- 2014DORZOLAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 202053 · REGCON HOLDINGS
- 2013DORZOLAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 091034 · ZAMBON SPA
- 2009DORZOLAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 079186 · AM REGENT
- 2009DORZOLAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 090143 · BAUSCH AND LOMB
- 2009DORZOLAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 078981 · SANDOZ
- 2008DORZOLAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 078756 · TEVA PHARMS
- 2008DORZOLAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 078748 · SANDOZ
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.
