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DAPIPRAZOLE HYDROCHLORIDE

ANDA

DAPIPRAZOLE HYDROCHLORIDE | A204902 | BARADAINA LLC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
CUSTOpharm, Inc. - Citizen Petition FDA-2012-P-1000 CUSTOpharm, Inc. filed this citizen petition under section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA Commissioner determine that Dapiprazole Hydrochloride Ophthalmic Solution 0.5%, the reference listed drug approved under NDA 19-849, was not withdrawn for safety	505(q)	2012-09-28	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ANGELINI ACRAF SPADAPIPRAZOLE HYDROCHLORIDE

DMF 43341981

NEULAND LABORATORIES LTDDAPIPRAZOLE HYDROCHLORIDE

DMF 263472012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 17, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5%

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: May 30, 2019

No patent or exclusivity listings for this strength.