Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076757
Company: HIKMA FARMACEUTICA

Products on ANDA 076757

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIPROFLOXACIN IN DEXTROSE 5%	CIPROFLOXACIN	200MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076757

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/21/2008	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
05/03/2019	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/18/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/18/2018	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/15/2018	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/15/2018	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
06/25/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/23/2011	SUPPL-2	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
07/09/2009	SUPPL-1	Labeling		Label is not available on this site.