An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020719
Company: SANKYO

Products on NDA 020719

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020719

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/1997	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY		Label is not available on this site.

Supplements

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) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20719S12_Prelay_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20719S12_Prelay_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20719S12_Prelay.cfm
11/02/1998	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
02/04/1998	SUPPL-7	Labeling		Label is not available on this site.
06/28/1999	SUPPL-6	Efficacy-New Indication	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/020719Orig1s006.pdf
08/04/1997	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
04/08/1997	SUPPL-4	Labeling		Label is not available on this site.
08/04/1997	SUPPL-3	Efficacy-New Indication		Label is not available on this site.
08/04/1997	SUPPL-2	Efficacy-New Indication		Label is not available on this site.
04/08/1997	SUPPL-1	Labeling		Label is not available on this site.

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

Top