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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-three 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
Formulation / Manufacturing:see details

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

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.