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Last Updated: November 21, 2024

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.
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 ActionCyclooxygenase 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:RXDosage:SOLUTION;INTRAVENOUSStrength1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)
Approval Date:Oct 17, 2023TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 17, 2026
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Jan 14, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jul 17, 2035Product Flag?YSubstance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.