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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076093
Company: LARKEN LABS

Products on ANDA 076093

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OFLOXACIN	OFLOXACIN	200MG	TABLET;ORAL	Discontinued	None	No	No
OFLOXACIN	OFLOXACIN	300MG	TABLET;ORAL	Discontinued	None	No	No
OFLOXACIN	OFLOXACIN	400MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076093

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/02/2003	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76093.ta.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2019	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/18/2018	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/26/2016	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/26/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
03/20/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/22/2014	SUPPL-6	Labeling		Label is not available on this site.
03/05/2015	SUPPL-5	Labeling-Package Insert, Labeling-Container/Carton Labels, REMS-Modified		Label is not available on this site.
11/04/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/22/2005	SUPPL-2	Labeling		Label is not available on this site.
04/05/2005	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076093

OFLOXACIN

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OFLOXACIN	OFLOXACIN	400MG	TABLET;ORAL	Prescription	No	AB	091656	CADILA PHARMS LTD
OFLOXACIN	OFLOXACIN	400MG	TABLET;ORAL	Prescription	No	AB	077098	DR REDDYS LABS LTD
OFLOXACIN	OFLOXACIN	400MG	TABLET;ORAL	Prescription	No	AB	076093	LARKEN LABS
OFLOXACIN	OFLOXACIN	400MG	TABLET;ORAL	Prescription	No	AB	076182	TEVA

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