You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 16, 2024

Details for New Drug Application (NDA): 022165

✉ Email this page to a colleague

« Back to Dashboard

NDA 022165 describes CAMBIA, which is a drug marketed by Assertio and is included in one NDA. It is available from two suppliers. 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. Thirty-five 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

Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Prostaglandin Production

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	50MG
Approval Date:	Jun 17, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Jun 16, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
Patent:	⤷ Try a Trial	Patent Expiration:	Jun 16, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
Patent:	⤷ Try a Trial	Patent Expiration:	Jun 16, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS

Expired US Patents for NDA 022165

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	⤷ Try a Trial	⤷ Try a Trial
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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.