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Last Updated: April 27, 2024

Details for New Drug Application (NDA): 022348

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NDA 022348 describes CALDOLOR, which is a drug marketed by Cumberland Pharms 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 are sixty-four drug master file entries for this compound. Two hundred and thirty-four suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

Summary for 022348

Tradename:	CALDOLOR
Applicant:	Cumberland Pharms
Ingredient:	ibuprofen
Patents:	10
Formulation / Manufacturing:	see details

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:	Nov 19, 2024
Regulatory Exclusivity Use:	CLINICAL TRIAL STUDY RESULTS
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:	Nov 19, 2024
Regulatory Exclusivity Use:	CLINICAL TRIAL STUDY RESULTS

Expired US Patents for NDA 022348

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009	⤷ Try a Trial	⤷ Try a Trial
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-001	Jun 11, 2009	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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 verification 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.