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Details for New Drug Application (NDA): 022382

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NDA 022382 describes SPRIX, which is a drug marketed by Egalet Us Inc 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 SPRIX profile page.

The generic ingredient in SPRIX is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

Summary for NDA: 022382

Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022382

Suppliers and Packaging for NDA: 022382

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ketorolac tromethamine
SPRAY, METERED;NASAL 022382 NDA Physicians Total Care, Inc. 54868-6284 54868-6284-0 5 BOTTLE, SPRAY in 1 CARTON (54868-6284-0) > 8 SPRAY, METERED in 1 BOTTLE, SPRAY
ketorolac tromethamine
SPRAY, METERED;NASAL 022382 NDA Egalet US Inc. 69344-144 69344-144-43 5 CARTON in 1 CARTON (69344-144-43) > 1 BOTTLE, SPRAY in 1 CARTON (69344-144-53) > 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength15.75MG/SPRAY
Approval Date:May 14, 2010TE:RLD:Yes
Patent:6,333,044Patent Expiration:Dec 25, 2018Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022382

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Egalet Us Inc
ketorolac tromethamine
SPRAY, METERED;NASAL022382-001May 14, 20107,476,689► 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.