Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076152
Company: AUROBINDO PHARMA USA

Products on ANDA 076152

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076152

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/13/2001	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
04/28/2021	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/24/2017	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
01/24/2017	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/29/2010	SUPPL-8	Labeling-Container/Carton Labels		Label is not available on this site.
10/25/2007	SUPPL-3	Labeling		Label is not available on this site.
06/15/2006	SUPPL-2	Labeling		Label is not available on this site.
06/12/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.