Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075910
Company: ACTAVIS ELIZABETH

Products on ANDA 075910

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 075910

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/07/2002	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
11/21/2024	SUPPL-31	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/12/2024	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-28	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/29/2021	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
10/26/2014	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
05/13/2009	SUPPL-16	Labeling		Label is not available on this site.
07/28/2006	SUPPL-9	Labeling		Label is not available on this site.
07/11/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.