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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 020037


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NDA 020037 describes VOLTAREN, which is a drug marketed by Novartis and Glaxosmithkline Cons 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. Sixty-six 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
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 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 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:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Mar 28, 1991TE:ATRLD:Yes

Expired US Patents for NDA 020037

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

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