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 forty-six 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 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: | 10 |
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 | |||||
| Regulatory Exclusivity Expiration: | May 11, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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: | May 11, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Mar 16, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ATERIOSIS WITH AQUEOUS COMPOSITION | ||||||||
Expired US Patents for NDA 022348
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cumberland Pharms | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-001 | Jun 11, 2009 | ⤷ Get Started Free | ⤷ Get Started Free |
| Cumberland Pharms | CALDOLOR | ibuprofen | SOLUTION;INTRAVENOUS | 022348-002 | Jun 11, 2009 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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