Details for New Drug Application (NDA): 019700

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NDA 019700 describes ACULAR, which is a drug marketed by Abbvie and 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. Sixty-nine suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

Summary for 019700

Tradename:	ACULAR
Applicant:	Abbvie
Ingredient:	ketorolac tromethamine
Patents:	0

Pharmacology for NDA: 019700

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 019700

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

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:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.5%
Approval Date:	Nov 9, 1992	TE:	AT	RLD:	Yes

Expired US Patents for NDA 019700

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	⤷ Sign Up	⤷ Sign Up
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	⤷ Sign Up	⤷ Sign Up
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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