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Serving 500+ biopharmaceutical companies globally:

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Generated: July 21, 2017

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 eight 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 fifty-five suppliers are listed for this compound. Additional details are available on the ibuprofen profile page.

Summary for NDA: 022348

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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
Patent:9,649,284Patent Expiration:Sep 30, 2029Product Flag?Substance Flag?Delist Request?
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.


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Serving 500+ biopharmaceutical companies globally:

Baxter
Mallinckrodt
Merck
Fuji
US Department of Justice
Julphar
Johnson and Johnson
QuintilesIMS
AstraZeneca
Novartis

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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