NDC 70377-082

DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE

Dorzolamide Hydrochloride Timolol Maleate

DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Biocon Pharma Inc.. The primary component is Dorzolamide Hydrochloride; Timolol Maleate.

Product ID70377-082_46ba7958-0844-4809-b1e4-2bbb5fa86459
NDC70377-082
Product TypeHuman Prescription Drug
Proprietary NameDORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE
Generic NameDorzolamide Hydrochloride Timolol Maleate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2022-01-08
Marketing CategoryANDA /
Application NumberANDA202054
Labeler NameBiocon Pharma Inc.
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 Through2023-12-31

Packaging

NDC 70377-082-11

1 BOTTLE, DISPENSING in 1 CARTON (70377-082-11) > 10 mL in 1 BOTTLE, DISPENSING
Marketing Start Date2022-01-08
NDC Exclude FlagN
Sample Package?N

Drug Details


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