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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 204168


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NDA 204168 describes FETZIMA, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FETZIMA profile page.

The generic ingredient in FETZIMA is levomilnacipran hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levomilnacipran hydrochloride profile page.
Summary for 204168
Tradename:FETZIMA
Applicant:Abbvie
Ingredient:levomilnacipran hydrochloride
Patents:3
Pharmacology for NDA: 204168
Suppliers and Packaging for NDA: 204168
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168 NDA Allergan, Inc. 0456-2200 0456-2200-07 1 BLISTER PACK in 1 CARTON (0456-2200-07) / 1 KIT in 1 BLISTER PACK (0456-2200-65) * 2 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2220-00) * 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2240-00)
FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168 NDA Allergan, Inc. 0456-2202 0456-2202-28 1 KIT in 1 BLISTER PACK (0456-2202-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Jul 25, 2013TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 2, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Patent:⤷  Try a TrialPatent Expiration:May 23, 2032Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Try a TrialPatent Expiration:Jan 11, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

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