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Details for New Drug Application (NDA): 022348
The generic ingredient in CALDOLOR is ibuprofen. There are sixty-four drug master file entries for this compound. Two hundred and forty-six 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: | 8 |
Therapeutic Class: | Analgesics Anti-inflammatory Agents |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022348
Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 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 | N | 66220-287-08 |
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 | |||||
Patent: | ➤ Try a Free Trial | Patent Expiration: | Nov 27, 2021 | Product Flag? | Y | 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 |
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 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. | ||||||||
Regulatory Exclusivity Expiration: | Nov 20, 2018 | ||||||||
Regulatory Exclusivity Use: | NEW PATIENT POPULATION |
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