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Last Updated: March 28, 2026

Details for New Drug Application (NDA): 205071


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NDA 205071 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 two suppliers. Additional details are available on the MILNACIPRAN HYDROCHLORIDE profile page.

The generic ingredient in MILNACIPRAN HYDROCHLORIDE is milnacipran hydrochloride. There are twenty-eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.
Summary for 205071
Tradename:MILNACIPRAN HYDROCHLORIDE
Applicant:Breckenridge
Ingredient:milnacipran hydrochloride
Patents:0
Pharmacology for NDA: 205071
Mechanism of ActionNorepinephrine Uptake Inhibitors
Serotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 205071
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205071 ANDA Breckenridge Pharmaceutical, Inc. 51991-034 51991-034-06 60 TABLET in 1 BOTTLE (51991-034-06)
MILNACIPRAN HYDROCHLORIDE milnacipran hydrochloride TABLET;ORAL 205071 ANDA Breckenridge Pharmaceutical, Inc. 51991-036 51991-036-06 60 TABLET in 1 BOTTLE (51991-036-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Jan 27, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jan 27, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 27, 2016TE:ABRLD:No

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Preferred Citation:

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