Details for New Drug Application (NDA): 020947

NDA 020947 describes PENNSAID, which is a drug marketed by Horizon and Nuvo Pharms Inc and is included in two NDAs. It is available from six suppliers. There are nineteen patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PENNSAID profile page.

The generic ingredient in PENNSAID is diclofenac sodium. There are forty-seven drug master file entries for this compound. One hundred and twenty-seven suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.

Summary for 020947

Tradename:	PENNSAID
Applicant:	Nuvo Pharms Inc
Ingredient:	diclofenac sodium
Patents:	4

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;TOPICAL			Strength	1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Nov 4, 2009	TE:		RLD:	Yes
Patent:	8,217,078	Patent Expiration:	Jul 10, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL MEDICATION ON THE SAME KNEE
Patent:	8,546,450	Patent Expiration:	Aug 9, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
Patent:	8,546,450	Patent Expiration:	Aug 9, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT

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