Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078024
Company: BAXTER HLTHCARE CORP

Products on ANDA 078024

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN	200MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN	400MG/200ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078024

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/18/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078024s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2024	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
09/09/2024	SUPPL-35	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/09/2024	SUPPL-31	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
05/06/2019	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
05/06/2019	SUPPL-29	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/18/2018	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/15/2018	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
01/27/2017	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/27/2017	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
06/07/2016	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/07/2016	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
06/07/2016	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2012	SUPPL-9	Labeling-Medication Guide, REMS-Modified		Label is not available on this site.
05/21/2012	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/16/2011	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/26/2010	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.
05/26/2009	SUPPL-3	Labeling		Label is not available on this site.
01/29/2009	SUPPL-2	Labeling		Label is not available on this site.