NDC 14445-405

DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE

Ddorzolamide Hydrochloride Timolol Maleate

DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Indoco Remedies Limited. The primary component is Dorzolamide Hydrochloride; Timolol Maleate.

Product ID14445-405_ad0940ba-ad02-47eb-9cc6-d974c211c538
NDC14445-405
Product TypeHuman Prescription Drug
Proprietary NameDORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE
Generic NameDdorzolamide Hydrochloride Timolol Maleate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2021-05-14
Marketing CategoryANDA /
Application NumberANDA202054
Labeler NameIndoco Remedies Limited
Substance NameDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active Ingredient Strength20 mg/mL; mg/mL
Pharm ClassesCarbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 14445-405-10

1 BOTTLE, DISPENSING in 1 CARTON (14445-405-10) > 10 mL in 1 BOTTLE, DISPENSING
Marketing Start Date2021-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 14445-405-10 [14445040510]

Dorzolamide Hydrochloride Timolol Maletae SOLUTION/ DROPS
Marketing CategoryEXPORT ONLY
Application NumberANDA202054
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-07-31
Marketing End Date2018-12-09

Drug Details


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