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FDA Orange Book · active-ingredient family

Dorzolamide hydrochloride

Dorzolamide hydrochloride is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TRUSOPT · NDA 020408

1

Brand (NDA)

14

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution/drops

ProductApplicantApplicationTEApproved
TRUSOPTRLDMSD SUB MERCKNDA 020408—Dec 09, 1994

Generic (ANDA) products (14)

ProductApplicantApplicationTEApproved
DORZOLAMIDE HYDROCHLORIDESOMERSET THERAPS LLCANDA 215004ATFeb 11, 2025
DORZOLAMIDE HYDROCHLORIDEGLANDANDA 215660ATJan 27, 2022
DORZOLAMIDE HYDROCHLORIDEMICRO LABSANDA 204778ATNov 08, 2019
DORZOLAMIDE HYDROCHLORIDEALEMBICANDA 212639ATAug 09, 2019
DORZOLAMIDE HYDROCHLORIDEFDC LTDANDA 205294ATJan 24, 2019
DORZOLAMIDE HYDROCHLORIDEREGCON HOLDINGSANDA 202053ATSep 11, 2014
DORZOLAMIDE HYDROCHLORIDEZAMBON SPAANDA 091034—Dec 04, 2013
DORZOLAMIDE HYDROCHLORIDEAM REGENTANDA 079186—Nov 18, 2009
DORZOLAMIDE HYDROCHLORIDEBAUSCH AND LOMBANDA 090143ATJun 25, 2009
DORZOLAMIDE HYDROCHLORIDESANDOZANDA 078981ATApr 13, 2009
DORZOLAMIDE HYDROCHLORIDETEVA PHARMSANDA 078756—Dec 04, 2008
DORZOLAMIDE HYDROCHLORIDESANDOZANDA 078748ATNov 06, 2008
DORZOLAMIDE HYDROCHLORIDEHIKMAANDA 077846—Oct 28, 2008
DORZOLAMIDE HYDROCHLORIDERUBICON RESEARCHANDA 078395ATOct 28, 2008

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.

Dorzolamide hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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