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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 020597


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NDA 020597 describes XALATAN, which is a drug marketed by Upjohn and is included in one NDA. It is available from three suppliers. Additional details are available on the XALATAN profile page.

The generic ingredient in XALATAN 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 020597
Tradename:XALATAN
Applicant:Upjohn
Ingredient:latanoprost
Patents:0
Suppliers and Packaging for NDA: 020597
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597 NDA PFIZER LABORATORIES DIV PFIZER INC 0013-8303 0013-8303-04 1 BOTTLE, DROPPER in 1 CARTON (0013-8303-04) / 2.5 mL in 1 BOTTLE, DROPPER
XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597 NDA Viatris Specialty LLC 58151-419 58151-419-35 1 BOTTLE, DROPPER in 1 CARTON (58151-419-35) / 2.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.005%
Approval Date:Jun 5, 1996TE:ATRLD:Yes

Expired US Patents for NDA 020597

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996 ⤷  Sign Up ⤷  Sign Up
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996 ⤷  Sign Up ⤷  Sign Up
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996 ⤷  Sign Up ⤷  Sign Up
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996 ⤷  Sign Up ⤷  Sign Up
Upjohn XALATAN latanoprost SOLUTION/DROPS;OPHTHALMIC 020597-001 Jun 5, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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