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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076717
Company: HIKMA FARMACEUTICA

Products on ANDA 076717

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIPROFLOXACIN	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
CIPROFLOXACIN	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076717

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2009	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-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/16/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/18/2018	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
10/15/2018	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/15/2018	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/25/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
06/23/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076717

CIPROFLOXACIN

INJECTABLE;INJECTION; 200MG/20ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIPROFLOXACIN	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078062	BAXTER HLTHCARE CORP
CIPROFLOXACIN	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076717	HIKMA FARMACEUTICA

INJECTABLE;INJECTION; 400MG/40ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIPROFLOXACIN	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	078062	BAXTER HLTHCARE CORP
CIPROFLOXACIN	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	076717	HIKMA FARMACEUTICA

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