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NDA

PRILOCAINE HYDROCHLORIDE | N021382 | DENTSPLY PHARMACEUTICAL INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain8 active DMFs2 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVPRILOCAINE USP

DMF 157722001

MOEHS IBERICA SLPRILOCAINE HYDROCHLORIDE

DMF 275862013

NORTEC QUIMICA SAPRILOCAINE

DMF 322832017

MOEHS IBERICA SLPRILOCAINE

DMF 328182018

SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO LTDPRILOCAINE HYDROCHLORIDE

DMF 347012020

SWATI SPENTOSE PRIVATE LTDPRILOCAINE USP

DMF 352602020

SWATI SPENTOSE PRIVATE LTDPRILOCAINE HYDROCHLORIDE USP

DMF 353342021

APEX HEALTHCARE LTDPRILOCAINE USP

DMF 419052025

WYCKOFF CHEMICAL CO INCInactivePRILOCAINE HYDROCHLORIDE USP

DMF 59481985

GUFIC BIOSCIENCES LTDInactivePRILOCAINE USP

DMF 252522011

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 7, 2018	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4%

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.