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Last Updated: June 19, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202442


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NDA 202442 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 202442
Tradename:LATANOPROST
Applicant:Fdc Ltd
Ingredient:latanoprost
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202442
Suppliers and Packaging for NDA: 202442
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 202442 ANDA Rising Pharmaceuticals, Inc. 64980-516 64980-516-25 1 BOTTLE, DROPPER in 1 CARTON (64980-516-25) > 2.5 mL in 1 BOTTLE, DROPPER
LATANOPROST latanoprost SOLUTION/DROPS;OPHTHALMIC 202442 ANDA NuCare Pharmaceuticals,Inc. 68071-4893 68071-4893-2 2.5 mL in 1 BOX (68071-4893-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.005%
Approval Date:Apr 22, 2016TE:ATRLD:No

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