Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020720
Company: PFIZER PHARMS
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 |