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Details for New Drug Application (NDA): 019201
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The generic ingredient in VOLTAREN is diclofenac sodium. There are forty-seven drug master file entries for this compound. Ninety-one 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| TABLET, DELAYED RELEASE;ORAL | Strength | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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| TABLET, DELAYED RELEASE;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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| TABLET, DELAYED RELEASE;ORAL | Strength | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
Approval Date: | Jul 28, 1988 | TE: | RLD: | Yes |
Expired US Patents for NDA 019201
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 | Start Trial | Start Trial |
Novartis | VOLTAREN | diclofenac sodium | TABLET, DELAYED RELEASE;ORAL | 019201-001 | Jul 28, 1988 | Start Trial | Start Trial |
Novartis | VOLTAREN | diclofenac sodium | TABLET, DELAYED RELEASE;ORAL | 019201-002 | Jul 28, 1988 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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