Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020632
Company: ABBOTT
Company: ABBOTT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MERIDIA | SIBUTRAMINE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Discontinued | None | No | No |
| MERIDIA | SIBUTRAMINE HYDROCHLORIDE | 10MG | CAPSULE;ORAL | Discontinued | None | No | No |
| MERIDIA | SIBUTRAMINE HYDROCHLORIDE | 15MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 11/22/1997 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20632_meridia.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/04/2010 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020632s034,s035ltr.pdf | |
| 08/04/2010 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020632s034,s035ltr.pdf | |
| 05/04/2009 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020632s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020632s032ltr.pdf | |
| 12/24/2008 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020632s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s031ltr.pdf | |
| 05/29/2008 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s030, 020381s032ltr.pdf |
| 08/23/2006 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020632s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020632s026ltr.pdf | |
| 07/29/2005 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020632s024ltr.pdf | |
| 12/08/2005 | SUPPL-21 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020632s021ltr.pdf | |
| 11/24/2004 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20632s019,020ltr.pdf |
| 11/24/2004 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20632s019,020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20632s019,020ltr.pdf | |
| 09/25/2003 | SUPPL-17 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20632slr017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020632_S017_MERIDIA_AP.pdf |
| 10/08/2002 | SUPPL-15 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020632_S015_MERIDIA.pdf |
| 08/07/2002 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020632_S014_MERIDIA.pdf |
| 04/25/2002 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/2001 | SUPPL-11 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20632S008011ltr.pdf | |
| 02/16/2001 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20632S008011ltr.pdf | |
| 11/12/1999 | SUPPL-6 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020632_S006_MERIDIA_CAPSULES.pdf |
| 07/06/1999 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020632_S004_MERIDA_CAPSULES.pdf |
| 08/07/1998 | SUPPL-2 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020632_S002_MERIDIA_CAPSULES.pdf |
| 08/07/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/04/2010 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf | |
| 08/04/2010 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020632s034s035lbl.pdf | |
| 05/04/2009 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020632s032lbl.pdf | |
| 12/24/2008 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020632s031lbl.pdf | |
| 08/23/2006 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020632s026lbl.pdf | |
| 12/08/2005 | SUPPL-21 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s021lbl.pdf | |
| 07/29/2005 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020632s024lbl.pdf | |
| 11/24/2004 | SUPPL-19 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20632s019,020lbl.pdf | |
| 02/16/2001 | SUPPL-11 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf | |
| 02/16/2001 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20632s8s11LBL.pdf |