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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 020037

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NDA 020037 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 020037

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

Pharmacology for NDA: 020037

Mechanism of Action	Acidifying Activity Calcium Chelating Activity
Physiological Effect	Decreased Coagulation Factor Activity

Suppliers and Packaging for NDA: 020037

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VOLTAREN	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020037	NDA	Citra Labs LLC	23731-6051	23731-6051-1	10 VIAL, SINGLE-USE in 1 CASE (23731-6051-1) / 30 mL in 1 VIAL, SINGLE-USE (23731-6051-3)
VOLTAREN	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020037	NDA	Citra Labs LLC	23731-6051	23731-6051-2	25 VIAL, SINGLE-USE in 1 CASE (23731-6051-2) / 30 mL in 1 VIAL, SINGLE-USE (23731-6051-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.1%
Approval Date:	Mar 28, 1991	TE:		RLD:	Yes

Expired US Patents for NDA 020037

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	VOLTAREN	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020037-001	Mar 28, 1991	⤷ Try a Trial	⤷ Try a Trial
Novartis	VOLTAREN	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020037-001	Mar 28, 1991	⤷ Try a Trial	⤷ Try a Trial
Novartis	VOLTAREN	diclofenac sodium	SOLUTION/DROPS;OPHTHALMIC	020037-001	Mar 28, 1991	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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