Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091482

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FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE)
100MG
Marketing Status: Prescription

Active Ingredient: FLUVOXAMINE MALEATE
Proprietary Name: FLUVOXAMINE MALEATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091482
Product Number: 001
Approval Date: Apr 23, 2013
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE)
150MG
Marketing Status: Prescription

Active Ingredient: FLUVOXAMINE MALEATE
Proprietary Name: FLUVOXAMINE MALEATE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A091482
Product Number: 002
Approval Date: Nov 18, 2013
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC
Marketing Status:  Prescription
Patent and Exclusivity Information