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Generated: May 29, 2017
| Tradename: | 1 |
| Applicant: | 1 |
| Ingredient: | 1 |
| Patents: | 1 |
| Therapeutic Class: | Analgesics Anti-inflammatory Agents |
| Formulation / Manufacturing: | see details |
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| 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 |
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 400MG/4ML (100MG/ML) | ||||
| Approval Date: | Jun 11, 2009 | TE: | RLD: | No | |||||
| Patent: | 6,727,286 | 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 | ||||||||
| 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. | ||||||||
| Patent: | 6,727,286 | 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 | ||||||||
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