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 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. Forty-two 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

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:	⤷ Sign Up	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:	⤷ Sign Up	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:	⤷ Sign Up	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	⤷ Sign Up	⤷ Sign Up
Assertio	CAMBIA	diclofenac potassium	FOR SOLUTION;ORAL	022165-001	Jun 17, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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