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Last Updated: July 10, 2020

DrugPatentWatch Database Preview

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 twenty-two 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 ActionCyclooxygenase 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:DISCNDosage:SOLUTION;INTRAVENOUSStrength400MG/4ML (100MG/ML)
Approval Date:Jun 11, 2009TE:RLD:No
Patent:  Start TrialPatent Expiration:Nov 27, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength800MG/8ML (100MG/ML)
Approval Date:Jun 11, 2009TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Nov 27, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
Patent:  Start TrialPatent Expiration:Sep 30, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY

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