Drugs@FDA: FDA Approved Drug Products

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