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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078431
Company: HIKMA FARMACEUTICA

Products on ANDA 078431

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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 078431

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/18/2009	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-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/16/2019	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/18/2018	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/15/2018	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/15/2018	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/25/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
07/07/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078431

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

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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