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McKesson
Baxter
Cerilliant
Harvard Business School
Fuji
Chubb
QuintilesIMS
Teva
Mallinckrodt

Generated: April 22, 2018

DrugPatentWatch Database Preview

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 two 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. Forty-five 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
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
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 N 0023-9277-05
ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528 NDA AUTHORIZED GENERIC Pacific Pharma, Inc. 60758-773 N 60758-773-05

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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Serving hundreds of leading biopharmaceutical companies globally:

US Army
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Chubb
Federal Trade Commission
Chinese Patent Office
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Argus Health
Express Scripts
Johnson and Johnson

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