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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 091449

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NDA 091449 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 091449

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

Suppliers and Packaging for NDA: 091449

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	091449	ANDA	A-S Medication Solutions	50090-7062	50090-7062-0	2.5 mL in 1 BOTTLE (50090-7062-0)
LATANOPROST	latanoprost	SOLUTION/DROPS;OPHTHALMIC	091449	ANDA	Sandoz Inc	61314-547	61314-547-01	1 BOTTLE in 1 CARTON (61314-547-01) / 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:	Mar 22, 2011	TE:	AT	RLD:	No

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