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

Pharmacology for NDA: 022427

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 022427

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

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-DOSE in 1 CARTON (0023-3507-05) / .4 mL in 1 VIAL, SINGLE-DOSE
ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427	NDA	Allergan, Inc.	0023-3507	0023-3507-31	3 POUCH in 1 CARTON (0023-3507-31) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.45%
Approval Date:	Jul 22, 2009	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Aug 15, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Mar 7, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Aug 5, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022427

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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