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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 seven patents protecting this drug. Additional details are available on the CALDOLOR profile page.

The generic ingredient in CALDOLOR is ibuprofen. There are sixty-three drug master file entries for this compound. Two hundred and forty-two suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

Summary for NDA: 022348

Tradename:
CALDOLOR
Applicant:
Cumberland Pharms
Ingredient:
ibuprofen
Patents:7
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022348

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. 66220-287 66220-287-08 25 VIAL in 1 CARTON (66220-287-08) > 8 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength400MG/4ML (100MG/ML)
Approval Date:Jun 11, 2009TE:RLD:No
Patent:6,727,286Patent 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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength800MG/8ML (100MG/ML)
Approval Date:Jun 11, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 20, 2018
Regulatory Exclusivity Use:DOSING RECOMMENDATIONS AS NECESSARY FOR FEVER AND PAIN FOR AGES 6MO TO LESS THAN 12 YEARS AND 12 TO 17 YEARS.
Patent:6,727,286Patent 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


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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.

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