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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078252
Company: INFORLIFE

Products on ANDA 078252

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	Prescription	AP	No	No
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN	400MG/200ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078252

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/2008/078252s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/03/2019	SUPPL-32	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/16/2019	SUPPL-31	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/16/2019	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
10/18/2018	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
06/23/2016	SUPPL-22	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/28/2014	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/17/2013	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
03/13/2012	SUPPL-10	REMS-Proposal, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/23/2011	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/05/2009	SUPPL-5	REMS-Proposal, Labeling-Container/Carton Labels		Label is not available on this site.
06/19/2009	SUPPL-4	Labeling		Label is not available on this site.
12/19/2008	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078252

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 200MG/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN	200MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	078024	BAXTER HLTHCARE CORP
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN	200MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	077753	HOSPIRA
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN	200MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	078252	INFORLIFE

INJECTABLE;INJECTION; 400MG/200ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN	400MG/200ML	INJECTABLE;INJECTION	Prescription	No	AP	078024	BAXTER HLTHCARE CORP
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN	400MG/200ML	INJECTABLE;INJECTION	Prescription	No	AP	078431	HIKMA FARMACEUTICA
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN	400MG/200ML	INJECTABLE;INJECTION	Prescription	No	AP	077753	HOSPIRA
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CIPROFLOXACIN	400MG/200ML	INJECTABLE;INJECTION	Prescription	No	AP	078252	INFORLIFE

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