Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020719
Company: SANKYO
Company: SANKYO
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 |
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. |
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 |