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Drugs@FDA: FDA-Approved Drugs

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

Products on ANDA 060716

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 060716

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/1964	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/03/2025	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
03/29/2019	SUPPL-26	Labeling		Label is not available on this site.
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
05/15/2002	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/28/2000	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/28/2000	SUPPL-13	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
11/28/2000	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
05/31/1996	SUPPL-11	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/26/1996	SUPPL-10	Labeling		Label is not available on this site.
08/26/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/26/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/17/1992	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/03/1989	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.

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

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