Last Updated: November 10, 2026

Details for New Drug Application (NDA): 207399

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NDA 207399 describes MILNACIPRAN HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Breckenridge, Hetero Labs Ltd V, Macleods Pharms, and Strides Pharma, and is included in five NDAs. It is available from four 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. Seven suppliers are listed for this compound. Additional details are available on the milnacipran hydrochloride profile page.

Summary for 207399

Tradename:	MILNACIPRAN HYDROCHLORIDE
Applicant:	Strides Pharma
Ingredient:	milnacipran hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Sep 15, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Sep 15, 2026	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Sep 15, 2026	TE:	AB	RLD:	No

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