Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020741
Company: GEMINI LABS LLC
Company: GEMINI LABS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRANDIN | REPAGLINIDE | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| PRANDIN | REPAGLINIDE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| PRANDIN | REPAGLINIDE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/22/1997 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/020741s044lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/22/2019 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020741s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020741Orig1s044ltr.pdf | |
| 10/30/2015 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/2017 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020741s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020741Orig1s041,s042ltr.pdf | |
| 02/08/2017 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020741s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020741Orig1s041,s042ltr.pdf | |
| 03/01/2012 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020741s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020741s040ltr.pdf | |
| 07/29/2010 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020741s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020741s038ltr.pdf | |
| 06/10/2009 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020741s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020741s035ltr.pdf | |
| 07/14/2008 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020741s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020741s034ltr.pdf | |
| 06/19/2006 | SUPPL-30 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020741s030LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020741_S030_PRANDIN_TABS_AP.pdf |
| 02/10/2005 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20741s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20741s022ltr.pdf | |
| 10/15/2003 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20741scp019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020741_S019_PRANDIN_TABS_AP.pdf |
| 08/27/2003 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20741slr018_prandin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20741slr018ltr.pdf | |
| 11/25/2002 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020741_S016_PRANDIN_TABS_AP.pdf |
| 10/01/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020741_S015_PRANDIN_TABS_AP.pdf |
| 08/05/2002 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/21/2002 | SUPPL-13 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20741se1-013ltr.pdf | |
| 01/18/2002 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20741s12ltr.pdf | |
| 10/27/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/15/2000 | SUPPL-9 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020741_S009_PRANDIN_TABS_AP.pdf |
| 02/25/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/08/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1999 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1999 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/10/1999 | 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 |
|---|---|---|---|---|---|
| 01/22/2019 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020741s044lbl.pdf | |
| 02/08/2017 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020741s041s042lbl.pdf | |
| 02/08/2017 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020741s041s042lbl.pdf | |
| 03/01/2012 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020741s040lbl.pdf | |
| 07/29/2010 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020741s038lbl.pdf | |
| 06/10/2009 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020741s035lbl.pdf | |
| 07/14/2008 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020741s034lbl.pdf | |
| 02/10/2005 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20741s022lbl.pdf | |
| 08/27/2003 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20741slr018_prandin_lbl.pdf | |
| 10/21/2002 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s13lbl.pdf | |
| 01/18/2002 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s12lbl.pdf | |
| 12/22/1997 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/020741s044lbl.pdf |