Last Updated: September 26, 2026

Details for New Drug Application (NDA): 205081


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NDA 205081 describes MILNACIPRAN HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Breckenridge, and Hetero Labs Ltd V, and is included in three NDAs. It is available from three suppliers. Additional details are available on the MILNACIPRAN HYDROCHLORIDE profile page.

The generic ingredient in MILNACIPRAN HYDROCHLORIDE is milnacipran hydrochloride. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.
Summary for 205081
Tradename:MILNACIPRAN HYDROCHLORIDE
Applicant:Amneal Pharms
Ingredient:milnacipran hydrochloride
Patents:0
Pharmacology for NDA: 205081
Mechanism of ActionNorepinephrine Uptake Inhibitors
Serotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 205081
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205081 ANDA Amneal Pharmaceuticals LLC 65162-091 65162-091-06 60 TABLET in 1 BOTTLE (65162-091-06)
MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205081 ANDA Amneal Pharmaceuticals LLC 65162-092 65162-092-06 60 TABLET in 1 BOTTLE (65162-092-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Apr 22, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Apr 22, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Apr 22, 2016TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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