Orange Book product · Generic (ANDA)
TIMOLOL MALEATE
TIMOLOL MALEATE
At a glance
Mar 23, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 23, 2023
3 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
TIMOLOL MALEATE
Strength
EQ 0.5% BASE
Dosage form
SOLUTION, GEL FORMING/DROPS
Route
OPHTHALMIC
TE code
AB
Application
ANDA 213540
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TIMOLOL MALEATE
- 2004ISTALOLBrand (NDA)
NDA 021516 · BAUSCH AND LOMB
- 1998TIMOLOL MALEATEBrand (NDA)
NDA 020963 · SANDOZ
- 1993TIMOPTIC-XEBrand (NDA)
NDA 020330 · BAUSCH AND LOMB INC
- 1986TIMOPTIC IN OCUDOSEBrand (NDA)
NDA 019463 · 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
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.
