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Details for New Drug Application (NDA): 021528

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

Summary for NDA: 021528

ketorolac tromethamine
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents

Pharmacology for NDA: 021528

Suppliers and Packaging for NDA: 021528

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC 021528 NDA AUTHORIZED GENERIC Physicians Total Care, Inc. 54868-6416 54868-6416-0 1 BOTTLE, DROPPER in 1 CARTON (54868-6416-0) > 5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.4%
Approval Date:May 30, 2003TE:ATRLD:Yes
Patent:8,008,338*PEDPatent Expiration:Nov 24, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:8,207,215*PEDPatent Expiration:Nov 28, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:8,377,982*PEDPatent Expiration:Nov 28, 2024Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021528

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC021528-001May 30, 20035,110,493*PED► subscribe
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