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AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

NDA

AMIKACIN SULFATE | N050618 | APOTHECON INC DIV BRISTOL MYERS SQUIBB

2 strengths0 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 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.

Products (2)

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#001 — EQ 10MG BASE/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Nov 30, 1987

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Nov 30, 1987