NDC 68083-457

Timolol Maleate Ophthalmic Gel Forming Solution

Timolol Maleate Ophthalmic Gel Forming Solution

Timolol Maleate Ophthalmic Gel Forming Solution is a Ophthalmic Solution, Gel Forming / Drops in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Timolol Maleate.

Product ID68083-457_b7be50b2-d01e-4ee1-bb60-2393a9908203
NDC68083-457
Product TypeHuman Prescription Drug
Proprietary NameTimolol Maleate Ophthalmic Gel Forming Solution
Generic NameTimolol Maleate Ophthalmic Gel Forming Solution
Dosage FormSolution, Gel Forming / Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2022-06-24
Marketing CategoryANDA /
Application NumberANDA214645
Labeler NameGland Pharma Limited
Substance NameTIMOLOL MALEATE
Active Ingredient Strength3 mg/mL
Pharm ClassesAdrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68083-457-01

1 BOTTLE in 1 CARTON (68083-457-01) > 5 mL in 1 BOTTLE
Marketing Start Date2022-06-24
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Timolol Maleate Ophthalmic Gel Forming Solution" or generic name "Timolol Maleate Ophthalmic Gel Forming Solution"

NDCBrand NameGeneric Name
68083-457Timolol Maleate Ophthalmic Gel Forming SolutionTimolol Maleate Ophthalmic Gel Forming Solution
72266-199Timolol Maleate Ophthalmic Gel Forming SolutionTimolol Maleate Ophthalmic Gel Forming Solution

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.