Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020719
Company: SANKYO

Products on NDA 20719

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRELAY	TROGLITAZONE	200MG	TABLET;ORAL	Discontinued	None	No	No
PRELAY	TROGLITAZONE	400MG	TABLET;ORAL	Discontinued	None	No	No
PRELAY	TROGLITAZONE	300MG	TABLET;ORAL	Discontinued	None	No	No

Labels for NDA 020719

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/01/1999	SUPPL-12	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20719S12_Prelay_prntlbl.pdf