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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020720
Company: PFIZER PHARMS

Products on NDA 020720

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020720

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 1 - New Molecular Entity	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
06/16/1999	SUPPL-14	Labeling	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20720s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20720s12.ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20720S12S14_Rezulin.cfm
06/16/1999	SUPPL-12	Efficacy-New Indication	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20720s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20720s12.ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20720S12S14_Rezulin.cfm
07/22/1998	SUPPL-10	Labeling		Label is not available on this site.
11/02/1998	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
12/15/1997	SUPPL-7	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020720a_s001_thru_s007.pdf
11/19/1997	SUPPL-6	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020720a_s001_thru_s007.pdf
08/04/1997	SUPPL-5	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020720_s02_s03_s05ap.pdf
04/04/1997	SUPPL-4	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020720a_s001_thru_s007.pdf
08/04/1997	SUPPL-3	Efficacy-New Indication	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020720_s02_s03_s05ap.pdf
08/04/1997	SUPPL-2	Efficacy-New Indication	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020720_s02_s03_s05ap.pdf
04/04/1997	SUPPL-1	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020720a_s001_thru_s007.pdf

Labels for NDA 020720

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/1999	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20720s12lbl.pdf
06/16/1999	SUPPL-12	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20720s12lbl.pdf

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