Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 060716
Company: HIKMA

Products on ANDA 60716

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	Discontinued	None	No	No

Labels for ANDA 060716

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2012	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/060716Orig1s020Lbl.pdf
01/27/2012	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/060716s018lbl.pdf