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Last Updated: June 28, 2022

Details for New Drug Application (NDA): 019700


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NDA 019700 describes ACULAR, which is a drug marketed by Allergan and is included in three NDAs. It is available from one supplier. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ACULAR profile page.

The generic ingredient in ACULAR is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
Summary for 019700
Tradename:ACULAR
Applicant:Allergan
Ingredient:ketorolac tromethamine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019700
Mechanism of Action Cyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 019700
Suppliers and Packaging for NDA: 019700
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700 NDA Allergan, Inc. 0023-2181 0023-2181-05 1 BOTTLE, DROPPER in 1 CARTON (0023-2181-05) > 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Nov 9, 1992TE:ATRLD:Yes

Expired US Patents for NDA 019700

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 See Plans and Pricing See Plans and Pricing
Allergan ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 See Plans and Pricing See Plans and Pricing
Allergan ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
Mallinckrodt
Johnson and Johnson
Colorcon
Baxter

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