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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021693
Company: SHIONOGI INC

Products on NDA 021693

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RYBIX ODT	TRAMADOL HYDROCHLORIDE	50MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021693

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/05/2005	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021693lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021693ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021693s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/25/2010	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021693s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021693s004ltr.pdf
08/13/2010	SUPPL-2	Labeling-Proprietary Name Change	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021693s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021693s002ltr.pdf
07/12/2006	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021693s001ltr.pdf

Labels for NDA 021693

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/13/2010	SUPPL-2	Labeling-Proprietary Name Change	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021693s002lbl.pdf
06/25/2010	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021693s004lbl.pdf
05/05/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021693lbl.pdf

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