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Last Updated: April 20, 2024

Details for New Drug Application (NDA): 019201

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NDA 019201 describes VOLTAREN, which is a drug marketed by Novartis and Haleon Us Holdings and is included in four NDAs. It is available from one supplier. Additional details are available on the VOLTAREN profile page.

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

Summary for 019201

Tradename:	VOLTAREN
Applicant:	Novartis
Ingredient:	diclofenac sodium
Patents:	0
Formulation / Manufacturing:	see details

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 28, 1988	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 28, 1988	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 28, 1988	TE:		RLD:	Yes

Expired US Patents for NDA 019201

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	VOLTAREN	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	019201-003	Jul 28, 1988	⤷ Try a Trial	⤷ Try a Trial
Novartis	VOLTAREN	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	019201-001	Jul 28, 1988	⤷ Try a Trial	⤷ Try a Trial
Novartis	VOLTAREN	diclofenac sodium	TABLET, DELAYED RELEASE;ORAL	019201-002	Jul 28, 1988	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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