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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 202442

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NDA 202442 describes LATANOPROST, which is a drug marketed by Amring Pharms, Apotex Inc, Bausch And Lomb, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Gland, Micro Labs, Pharmobedient, Sandoz, and Somerset, and is included in twelve NDAs. It is available from eleven suppliers. Additional details are available on the LATANOPROST profile page.

The generic ingredient in LATANOPROST is latanoprostene bunod. Two suppliers are listed for this compound. Additional details are available on the latanoprostene bunod profile page.

Summary for 202442

Tradename:	LATANOPROST
Applicant:	Fdc Ltd
Ingredient:	latanoprost
Patents:	0

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 Pharma Holdings, Inc.	64980-516	64980-516-25	1 BOTTLE, DROPPER in 1 CARTON (64980-516-25) / 2.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.005%
Approval Date:	Apr 22, 2016	TE:	AT	RLD:	No

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