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ROPIVACAINE HYDROCHLORIDE

ANDA

ROPIVACAINE HYDROCHLORIDE | A204636 | RISING PHARMA HOLDINGS INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: NAROPIN(TE code: AP)

API Supply Chain12 active DMFs4 inactive

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

EXCELLA GMBH AND CO KGROPIVACAINE HYDROCHLORIDE

DMF 182882005

NAVINTA LLCROPIVACAINE

DMF 190842005

FINE CHEMICALS CORP PTY LTDROPIVACAINE HYDROCHLORIDE

DMF 206542007

FINE CHEMICALS CORP PTY LTDROPIVACAINE

DMF 232392009

JUBILANT PHARMOVA LTDROPIVACAINE HYDROCHLORIDE USP

DMF 249482011

SHANDONG ANHONG PHARMACEUTICAL CO LTDROPIVACAINE HYDROCHLORIDE (NON STERILE, API)

DMF 253782011

DISHMAN CARBOGEN AMCIS LTDROPIVACAINE HYDROCHLORIDE MONOHYDRATE

DMF 255062011

NAVINTA LLCROPIVACAINE HYDROCHLORIDE USP

DMF 301522016

EMCURE PHARMACEUTICALS LTDROPIVACAINE HYDROCHLORIDE USP (PROCESS II)

DMF 302172016

EDMOND PHARMA SRLROPIVACAINE HYDROCHLORIDE MONOHYDRATE

DMF 354012020

MOEHS IBERICA SLROPIVACAINE HYDROCHLORIDE

DMF 355682021

APEX HEALTHCARE LTDROPIVACAINE HYDROCHLORIDE USP

DMF 424812025

DISHMAN CARBOGEN AMCIS LTDInactiveROPIVACAINE HYDROCHLORIDE ANHYDROUS

DMF 220232008

FRESENIUS KABI ONCOLOGY LTDInactiveROPIVACAINE HYDROCHLORIDE

DMF 266502012

MAC CHEM PRODUCTS INDIA PVT LTDInactiveROPIVACAINE HYDROCHLORIDE MONOHYDRATE USP

DMF 270272013

FRESENIUS KABI ONCOLOGY LTDInactiveROPIVACAINE HYDROCHLORIDE ANHYDROUS

DMF 362332021

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 5, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 200MG/100ML (2MG/ML)

0 patents0 exclusivities▴

SOLUTION;INJECTION | Approved: Mar 16, 2018

No patent or exclusivity listings for this strength.

#002 — 400MG/200ML (2MG/ML)

0 patents0 exclusivities▾

SOLUTION;INJECTION | Approved: Mar 16, 2018