Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200158
Company: SANDOZ

Products on ANDA 200158

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No
DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200158

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/09/2013	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/19/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
05/19/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
05/19/2023	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
05/19/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
05/19/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
05/19/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
05/19/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/19/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.