Details for New Drug Application (NDA): 021528

NDA 021528 describes ACULAR LS, which is a drug marketed by Abbvie and is included in one NDA. It is available from three suppliers. There is one patent 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. Sixty-three suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

Summary for 021528

Tradename:	ACULAR LS
Applicant:	Abbvie
Ingredient:	ketorolac tromethamine
Patents:	1

Pharmacology for NDA: 021528

Mechanism of Action

Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 021528

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

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:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.4%
Approval Date:	May 30, 2003	TE:	AT	RLD:	Yes
Patent:	8,008,338*PED	Patent Expiration:	Nov 24, 2027	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021528

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	8,648,107
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	9,216,167
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	5,110,493*PED
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	8,946,281
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	8,906,950
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	8,541,463*PED
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	8,377,982*PED

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