Last Updated: September 24, 2026

Details for New Drug Application (NDA): 202442

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NDA 202442 describes LATANOPROST, which is a drug marketed by Apotex Inc, Bausch And Lomb, Carnegie, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Gland, J Molner, Mankind Pharma, Micro Labs, Sandoz, and Somerset, and is included in thirteen NDAs. It is available from fourteen suppliers. Additional details are available on the LATANOPROST profile page.

The generic ingredient in LATANOPROST is latanoprostene bunod. There are two drug master file entries for this compound. 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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