Orange Book product · Brand (NDA)
TIMOPTIC IN OCUDOSE
TIMOLOL MALEATE
At a glance
Nov 05, 1986
Approved
Brand (NDA)
Application
AT3
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 05, 1986
40 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
TIMOLOL MALEATE
Strength
EQ 0.25% BASE
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT3
Application
NDA 019463
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.
- 2004ISTALOLBrand (NDA)
NDA 021516 · BAUSCH AND LOMB
- 1998TIMOLOL MALEATEBrand (NDA)
NDA 020963 · SANDOZ
- 1993TIMOPTIC-XEBrand (NDA)
NDA 020330 · BAUSCH AND LOMB INC
- —TIMOPTICBrand (NDA)
NDA 018086 · BAUSCH AND LOMB INC
- —BLOCADRENBrand (NDA)
NDA 018017 · MERCK
- 2024TIMOLOL MALEATEGeneric (ANDA)
ANDA 210640 · SOMERSET THERAPS LLC
- 2024TIMOLOL MALEATEGeneric (ANDA)
ANDA 218460 · CAPLIN
- 2024TIMOLOL MALEATEGeneric (ANDA)
ANDA 217764 · SOMERSET
- 2024TIMOLOL MALEATEGeneric (ANDA)
ANDA 216653 · SOMERSET THERAPS LLC
- 2024TIMOLOL MALEATEGeneric (ANDA)
ANDA 216343 · AMNEAL
- 2023TIMOLOL MALEATEGeneric (ANDA)
ANDA 217343 · MICRO LABS
- 2023TIMOLOL MALEATEGeneric (ANDA)
ANDA 217195 · SENTISS PHARMA
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.
