Orange Book product · Brand (NDA)
COMBIGAN
BRIMONIDINE TARTRATE; TIMOLOL MALEATE
At a glance
Oct 30, 2007
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 30, 2007
18 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Strength
0.2%;EQ 0.5% BASE
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AB
Application
NDA 021398
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.
- 2025BRIMONIDINE TARTRATE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 219093 · CAPLIN
- 2024BRIMONIDINE TARTRATE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 217288 · AMNEAL
- 2024BRIMONIDINE TARTRATE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 216114 · SOMERSET
- 2024BRIMONIDINE TARTRATE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 214987 · GLENMARK PHARMS LTD
- 2023BRIMONIDINE TARTRATE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 215230 · ALEMBIC
- 2022BRIMONIDINE TARTRATE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 215598 · UPSHER SMITH LABS
- 2022BRIMONIDINE TARTRATE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 091086 · SENTISS
- 2022BRIMONIDINE TARTRATE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 201949 · REGCON HOLDINGS
- 2022BRIMONIDINE TARTRATE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 091442 · APOTEX
- 2022BRIMONIDINE TARTRATE AND TIMOLOL MALEATEGeneric (ANDA)
ANDA 091087 · 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.
