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PRILOCAINE HYDROCHLORIDE

ANDA

PRILOCAINE HYDROCHLORIDE | A079235 | SEPTODONT INC

1 strength0 unique patents0 unique exclusivities

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
Oct 4, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4%

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 29, 2010

No patent or exclusivity listings for this strength.