Last Updated: September 24, 2026

Details for New Drug Application (NDA): 218257

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NDA 218257 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 218257

Tradename:	LATANOPROST
Applicant:	Gland
Ingredient:	latanoprost
Patents:	0

Suppliers and Packaging for NDA: 218257

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	218257	ANDA	Sagent Pharmaceuticals	25021-001	25021-001-02	1 BOTTLE in 1 CARTON (25021-001-02) / 2.5 mL in 1 BOTTLE
LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	218257	ANDA	Gland Pharma Limited	68083-609	68083-609-01	1 BOTTLE in 1 CARTON (68083-609-01) / 2.5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.005%
Approval Date:	Nov 26, 2024	TE:	AT	RLD:	No

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