Orange Book product · Brand (NDA)
COSOPT
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
At a glance
Apr 07, 1998
Approved
Brand (NDA)
Application
AT1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 07, 1998
28 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Strength
EQ 2% BASE;EQ 0.5% BASE
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT1
Application
NDA 020869
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.
- 2012COSOPT PFBrand (NDA)
NDA 202667 · THEA PHARMA
- 2025DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 216308 · ALEMBIC THERAP
- 2023DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 217260 · INGENUS PHARMS LLC
- 2022DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 215520 · GLAND
- 2022DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 215936 · MICRO LABS
- 2021DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 207629 · EUGIA PHARMA
- 2021DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 213099 · ALEMBIC
- 2020DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 204777 · MICRO LABS
- 2019DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 207523 · SOMERSET
- 2019DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 205295 · FDC LTD
- 2018DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 207630 · EUGIA PHARMA
- 2014DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 201998 · CHARTWELL MOLECULAR
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.
