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Generated: November 18, 2018

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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 two suppliers. 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-nine 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
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
ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700 NDA Rebel Distributors Corp. 21695-463 21695-463-05 5 mL in 1 BOTTLE (21695-463-05)

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 ➤ Sign Up ➤ Sign Up
Allergan ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 ➤ Sign Up ➤ Sign Up
Allergan 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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