Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204168

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FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE)
EQ 20MG BASE
Marketing Status: Prescription
Active Ingredient: LEVOMILNACIPRAN HYDROCHLORIDE
Proprietary Name: FETZIMA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N204168
Product Number: 001
Approval Date: Jul 25, 2013
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE)
EQ 40MG BASE
Marketing Status: Prescription
Active Ingredient: LEVOMILNACIPRAN HYDROCHLORIDE
Proprietary Name: FETZIMA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N204168
Product Number: 002
Approval Date: Jul 25, 2013
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE)
EQ 80MG BASE
Marketing Status: Prescription
Active Ingredient: LEVOMILNACIPRAN HYDROCHLORIDE
Proprietary Name: FETZIMA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 80MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N204168
Product Number: 003
Approval Date: Jul 25, 2013
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE)
EQ 120MG BASE
Marketing Status: Prescription
Active Ingredient: LEVOMILNACIPRAN HYDROCHLORIDE
Proprietary Name: FETZIMA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 120MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N204168
Product Number: 004
Approval Date: Jul 25, 2013
Applicant Holder Full Name: ALLERGAN SALES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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