Product Details for NDA 019201
VOLTAREN (DICLOFENAC SODIUM)
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DICLOFENAC SODIUM
Proprietary Name: VOLTAREN
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019201
Product Number: 001
Approval Date: Jul 28, 1988
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
VOLTAREN (DICLOFENAC SODIUM)
Proprietary Name: VOLTAREN
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019201
Product Number: 001
Approval Date: Jul 28, 1988
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DICLOFENAC SODIUM
Proprietary Name: VOLTAREN
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019201
Product Number: 002
Approval Date: Jul 28, 1988
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
VOLTAREN (DICLOFENAC SODIUM)
Proprietary Name: VOLTAREN
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019201
Product Number: 002
Approval Date: Jul 28, 1988
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DICLOFENAC SODIUM
Proprietary Name: VOLTAREN
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019201
Product Number: 003
Approval Date: Jul 28, 1988
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: VOLTAREN
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N019201
Product Number: 003
Approval Date: Jul 28, 1988
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status: Discontinued
Patent and Exclusivity Information