Product Details for NDA 022033
LUVOX CR (FLUVOXAMINE MALEATE)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLUVOXAMINE MALEATE
Proprietary Name: LUVOX CR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022033
Product Number: 001
Approval Date: Feb 28, 2008
Applicant Holder Full Name: JAZZ PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
LUVOX CR (FLUVOXAMINE MALEATE)
Proprietary Name: LUVOX CR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022033
Product Number: 001
Approval Date: Feb 28, 2008
Applicant Holder Full Name: JAZZ PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FLUVOXAMINE MALEATE
Proprietary Name: LUVOX CR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022033
Product Number: 002
Approval Date: Feb 28, 2008
Applicant Holder Full Name: JAZZ PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: LUVOX CR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022033
Product Number: 002
Approval Date: Feb 28, 2008
Applicant Holder Full Name: JAZZ PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information