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AMIKACIN SULFATE

ANDA

AMIKACIN SULFATE | A205604 | FRESENIUS KABI USA LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain2 active DMFs7 inactive

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

ACS DOBFAR SPAAMIKACIN SULFATE

DMF 137631998

SHANDONG ANXIN PHARMACEUTICAL CO LTDAMIKACIN SULFATE USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT

DMF 208742007

CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTDInactiveAMIKACIN SULFATE

DMF 106801993

GIST-BROCADES NV PHARMACEUTICALSInactiveAMIKACIN SULFATE

DMF 136511998

BRISTOL MYERS SQUIBB COInactiveAMIKACIN SULFATE

DMF 137221998

ABBOTT LABORATORIESInactiveAMIKACIN SULFATE

DMF 137561998

CHONGQING DAXIN PHARMACEUTICAL CO LTDInactiveAMIKACIN SULFATE (1:2) USP

DMF 137881998

PKUCARE CHONGQING DAXIN PHARMACEUTICAL CO LTDInactiveAmikacin Sulfate (1:1.8) USP, Non-Sterile Bulk Drug Substance

DMF 210352007

ZHEJIANG JINHUA CONBA BIO-PHARM CO LTDInactiveAMIKACIN SULFATE USP

DMF 277762013

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 11, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 250MG BASE/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 9, 2015

No patent or exclusivity listings for this strength.