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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 022427


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NDA 022427 describes ACUVAIL, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ACUVAIL profile page.

The generic ingredient in ACUVAIL is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
Summary for 022427
Tradename:ACUVAIL
Applicant:Abbvie
Ingredient:ketorolac tromethamine
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 022427
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 022427
Suppliers and Packaging for NDA: 022427
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACUVAIL ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 022427 NDA Allergan, Inc. 0023-3507 0023-3507-05 5 VIAL, SINGLE-USE in 1 CARTON (0023-3507-05) / .4 mL in 1 VIAL, SINGLE-USE
ACUVAIL ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 022427 NDA Allergan, Inc. 0023-3507 0023-3507-31 30 VIAL, SINGLE-USE in 1 CARTON (0023-3507-31) / .4 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.45%
Approval Date:Jul 22, 2009TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Aug 15, 2029Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Try a TrialPatent Expiration:Mar 7, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Aug 5, 2024Product Flag?YSubstance Flag?Delist Request?

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