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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 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.
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 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. | 66220-284 | 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: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 400MG/4ML (100MG/ML) | ||||
| Approval Date: | Jun 11, 2009 | TE: | RLD: | No | |||||
| Patent: | Start 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 | |||||
| Patent: | Start 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 | ||||||||
| Patent: | Start Trial | Patent Expiration: | Sep 30, 2029 | Product 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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