Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074391
Company: ROXANE

Products on ANDA 074391

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	25MG	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No
DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No
DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074391

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/1995	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
09/22/2006	SUPPL-12	Labeling		Label is not available on this site.
11/09/2001	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
11/09/2001	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/09/2001	SUPPL-9	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
11/09/2001	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
01/08/2002	SUPPL-7	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
01/08/2002	SUPPL-6	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
01/08/2002	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
03/09/2001	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
03/09/2001	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/22/1999	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/28/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.