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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022165


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NDA 022165 describes CAMBIA, which is a drug marketed by Assertio and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CAMBIA profile page.

The generic ingredient in CAMBIA is diclofenac potassium. There are forty-seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
Summary for 022165
Tradename:CAMBIA
Applicant:Assertio
Ingredient:diclofenac potassium
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 022165
Suppliers and Packaging for NDA: 022165
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165 NDA Assertio Therapeutics, Inc. 13913-011 13913-011-19 9 PACKET in 1 CARTON (13913-011-19) > 1 POWDER, FOR SOLUTION in 1 PACKET (13913-011-01)
CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165 NDA Assertio Therapeutics, Inc. 13913-012 13913-012-02 9 PACKET in 1 CARTON (13913-012-02) > 1 POWDER, FOR SOLUTION in 1 PACKET
Paragraph IV (Patent) Challenges for 022165
Tradename Dosage Ingredient NDA Submissiondate
CAMBIA FOR SOLUTION;ORAL diclofenac potassium 022165 2011-01-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength50MG
Approval Date:Jun 17, 2009TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jun 16, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
Patent:  Start TrialPatent Expiration:Jun 16, 2026Product Flag?YSubstance Flag?YDelist Request?
Patented Use:ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
Patent:  Start TrialPatent Expiration:Jun 16, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS

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Serving leading biopharmaceutical companies globally:

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