Details for New Drug Application (NDA): 022382

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NDA 022382 describes SPRIX, which is a drug marketed by Zyla and is included in one NDA. It is available from one supplier. 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. Sixty-nine suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

Summary for 022382

Tradename:	SPRIX
Applicant:	Zyla
Ingredient:	ketorolac tromethamine
Patents:	0

Pharmacology for NDA: 022382

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 022382

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 022382

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382	NDA	Zyla Life Sciences US LLC	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)
SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382	NDA	Zyla Life Sciences US LLC	69344-144	69344-144-53	1 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	15.75MG/SPRAY
Approval Date:	May 14, 2010	TE:		RLD:	Yes

Expired US Patents for NDA 022382

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010	⤷ Sign Up	⤷ Sign Up
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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