Details for New Drug Application (NDA): 020037
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The generic ingredient in VOLTAREN is diclofenac sodium. There are forty-seven drug master file entries for this compound. One hundred and twenty-eight 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 |
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | VOLTAREN | diclofenac sodium | SOLUTION/DROPS;OPHTHALMIC | 020037-001 | Mar 28, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | VOLTAREN | diclofenac sodium | SOLUTION/DROPS;OPHTHALMIC | 020037-001 | Mar 28, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | VOLTAREN | diclofenac sodium | SOLUTION/DROPS;OPHTHALMIC | 020037-001 | Mar 28, 1991 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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