Product Details for NDA 021519
LUVOX (FLUVOXAMINE MALEATE)
25MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
25MG
Marketing Status: Prescription
Active Ingredient: FLUVOXAMINE MALEATE
Proprietary Name: LUVOX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021519
Product Number: 001
Approval Date: Dec 20, 2007
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
LUVOX (FLUVOXAMINE MALEATE)
Proprietary Name: LUVOX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021519
Product Number: 001
Approval Date: Dec 20, 2007
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
50MG
Marketing Status: Prescription
Active Ingredient: FLUVOXAMINE MALEATE
Proprietary Name: LUVOX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021519
Product Number: 002
Approval Date: Dec 20, 2007
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
LUVOX (FLUVOXAMINE MALEATE)
Proprietary Name: LUVOX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021519
Product Number: 002
Approval Date: Dec 20, 2007
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
100MG
Marketing Status: Prescription
Active Ingredient: FLUVOXAMINE MALEATE
Proprietary Name: LUVOX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021519
Product Number: 003
Approval Date: Dec 20, 2007
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: LUVOX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021519
Product Number: 003
Approval Date: Dec 20, 2007
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information