Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202766
Company: XELLIA PHARMS APS

Products on ANDA 202766

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POLYMYXIN B SULFATE	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202766

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/15/2014	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 202766

POLYMYXIN B SULFATE

INJECTABLE;INJECTION; EQ 500,000 UNITS BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POLYMYXIN B SULFATE	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	063000	ADRASTEA PHARMA
POLYMYXIN B SULFATE	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206589	EUGIA PHARMA
POLYMYXIN B SULFATE	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065372	FRESENIUS KABI USA
POLYMYXIN B SULFATE	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207322	GLAND
POLYMYXIN B SULFATE	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	202766	XELLIA PHARMS APS