Last Updated: May 3, 2026

Details for New Drug Application (NDA): 204902

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NDA 204902 describes DAPIPRAZOLE HYDROCHLORIDE, which is a drug marketed by Baradaina Llc and Fera Pharms and is included in two NDAs. Additional details are available on the DAPIPRAZOLE HYDROCHLORIDE profile page.

The generic ingredient in DAPIPRAZOLE HYDROCHLORIDE is dapiprazole hydrochloride. There are two drug master file entries for this compound. Additional details are available on the dapiprazole hydrochloride profile page.

Summary for 204902

Tradename:	DAPIPRAZOLE HYDROCHLORIDE
Applicant:	Baradaina Llc
Ingredient:	dapiprazole hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.5%
Approval Date:	May 30, 2019	TE:		RLD:	No

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