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Generated: November 20, 2018

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Details for New Drug Application (NDA): 021528

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NDA 021528 describes ACULAR LS, which is a drug marketed by Allergan and is included in one NDA. It is available from three suppliers. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ACULAR LS profile page.

The generic ingredient in ACULAR LS is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
Summary for 021528
Tradename:ACULAR LS
Applicant:Allergan
Ingredient:ketorolac tromethamine
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 021528
Medical Subject Heading (MeSH) Categories for 021528
Suppliers and Packaging for NDA: 021528
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528 NDA Allergan, Inc. 0023-9277 0023-9277-05 1 BOTTLE, DROPPER in 1 CARTON (0023-9277-05) > 5 mL in 1 BOTTLE, DROPPER
ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528 NDA AUTHORIZED GENERIC A-S Medication Solutions 50090-3550 50090-3550-0 1 BOTTLE, DROPPER in 1 CARTON (50090-3550-0) > 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.4%
Approval Date:May 30, 2003TE:ATRLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 24, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Nov 28, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Nov 28, 2024Product Flag?Substance Flag?Delist Request?Y

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