Details for New Drug Application (NDA): 215320
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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: | ⤷ Sign Up | Patent Expiration: | Jan 14, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 17, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? |
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