Details for New Drug Application (NDA): 215320
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NDA 215320 describes COMBOGESIC IV, which is a drug marketed by Hikma and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the COMBOGESIC IV profile page.
The generic ingredient in COMBOGESIC IV is acetaminophen; ibuprofen sodium. There are sixty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; ibuprofen sodium profile page.
The generic ingredient in COMBOGESIC IV is acetaminophen; ibuprofen sodium. There are sixty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; ibuprofen sodium profile page.
Summary for 215320
| Tradename: | COMBOGESIC IV |
| Applicant: | Hikma |
| Ingredient: | acetaminophen; ibuprofen sodium |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215320
Generic Entry Date for 215320*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 215320
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 215320
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COMBOGESIC IV | acetaminophen; ibuprofen sodium | SOLUTION;INTRAVENOUS | 215320 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-9150 | 0143-9150-10 | 10 VIAL in 1 CARTON (0143-9150-10) / 100 mL in 1 VIAL (0143-9150-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) | ||||
| Approval Date: | Oct 17, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 17, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 11,213,498 | Patent Expiration: | Jan 14, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,389,416 | Patent Expiration: | Jul 17, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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