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Last Updated: August 4, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206519


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NDA 206519 describes LATANOPROST, which is a drug marketed by Akorn, Amring Pharms, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb, Dr Reddys Labs Ltd, Fdc Ltd, Sandoz Inc, and Somerset, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the LATANOPROST profile page.

The generic ingredient in LATANOPROST is latanoprost. There are twenty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the latanoprost profile page.
Summary for 206519
Tradename:LATANOPROST
Applicant:Aurobindo Pharma Ltd
Ingredient:latanoprost
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206519
Suppliers and Packaging for NDA: 206519
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 206519 ANDA Aurobindo Pharma Limited 65862-872 65862-872-25 1 BOTTLE in 1 CARTON (65862-872-25) > 2.5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrength0.005%
Approval Date:Sep 3, 2019TE:RLD:No

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