Product Details for ANDA 075888
FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE)
25MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
25MG
Marketing Status: Prescription
Active Ingredient: FLUVOXAMINE MALEATE
Proprietary Name: FLUVOXAMINE MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A075888
Product Number: 001
Approval Date: Nov 29, 2000
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE)
Proprietary Name: FLUVOXAMINE MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A075888
Product Number: 001
Approval Date: Nov 29, 2000
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
50MG
Marketing Status: Prescription
Active Ingredient: FLUVOXAMINE MALEATE
Proprietary Name: FLUVOXAMINE MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A075888
Product Number: 002
Approval Date: Nov 29, 2000
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE)
Proprietary Name: FLUVOXAMINE MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A075888
Product Number: 002
Approval Date: Nov 29, 2000
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
100MG
Marketing Status: Prescription
Active Ingredient: FLUVOXAMINE MALEATE
Proprietary Name: FLUVOXAMINE MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A075888
Product Number: 003
Approval Date: Nov 29, 2000
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: FLUVOXAMINE MALEATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A075888
Product Number: 003
Approval Date: Nov 29, 2000
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information