Last Updated: September 23, 2026

Details for New Drug Application (NDA): 022348

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NDA 022348 describes CALDOLOR, which is a drug marketed by Apotex and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the CALDOLOR profile page.

The generic ingredient in CALDOLOR is ibuprofen. There is one drug master file entry for this compound. Two hundred and fifty suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

Summary for 022348

Tradename:	CALDOLOR
Applicant:	Apotex
Ingredient:	ibuprofen
Patents:	10

Pharmacology for NDA: 022348

Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for 022348

Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Suppliers and Packaging for NDA: 022348

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348	NDA	Cumberland Pharmaceuticals Inc.	66220-284	66220-284-22	20 BAG in 1 CASE (66220-284-22) / 200 mL in 1 BAG (66220-284-11)
CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348	NDA	Cumberland Pharmaceuticals Inc.	66220-287	66220-287-08	25 VIAL in 1 CARTON (66220-287-08) / 8 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	400MG/4ML (100MG/ML)
Approval Date:	Jun 11, 2009	TE:		RLD:	No
Regulatory Exclusivity Expiration:	May 11, 2026
Regulatory Exclusivity Use:	NEW PATIENT POPULATION

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	800MG/8ML (100MG/ML)
Approval Date:	Jun 11, 2009	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 11, 2026
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Patent:	11,806,400	Patent Expiration:	Mar 16, 2032	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ATERIOSIS WITH AQUEOUS COMPOSITION

Expired US Patents for NDA 022348

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-001	Jun 11, 2009	6,727,286	⤷ Start Trial
Apotex	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009	6,727,286	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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