Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077782
Company: DR REDDYS

Products on ANDA 077782

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIPROFLOXACIN	CIPROFLOXACIN	200MG/20ML (10MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
CIPROFLOXACIN	CIPROFLOXACIN	400MG/40ML (10MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077782

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/28/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077782s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/03/2019	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/26/2019	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/26/2019	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/18/2018	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/26/2019	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
06/30/2014	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
06/23/2011	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/05/2009	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Medication Guide, REMS-Proposal		Label is not available on this site.
01/29/2009	SUPPL-2	Labeling		Label is not available on this site.