Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020036
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AREDIA | PAMIDRONATE DISODIUM | 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| AREDIA | PAMIDRONATE DISODIUM | 60MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| AREDIA | PAMIDRONATE DISODIUM | 90MG/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 10/31/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/20-036_aredia_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/pre96/20-036_apvl_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020036_aredia_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/31/2012 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020036s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020036s041ltr.pdf | |
| 04/07/2011 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020036s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020036s039ltr.pdf | |
| 12/12/2008 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020036s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020036s035ltr.pdf | |
| 12/11/2007 | SUPPL-34 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020036s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020036s034ltr.pdf | |
| 11/16/2005 | SUPPL-32 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020036s032ltr.pdf | |
| 10/11/2005 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020036s031ltr.pdf | |
| 02/02/2005 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20036s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20036s030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020036_s030_Aredia.pdf | |
| 03/24/2004 | SUPPL-29 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20036slr029ltr.pdf |
| 01/09/2004 | SUPPL-28 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20036slr028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020036_S028_AREDIA.pdf |
| 07/12/2002 | SUPPL-26 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20036se8026ltr.pdf |
| 02/12/2002 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/20/2001 | SUPPL-24 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20036s24lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20036s24ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-036S024_Aredia.pdf | |
| 11/15/2001 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/03/2002 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/2001 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/09/2003 | SUPPL-20 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20036slr020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020036_S020_AREDIA.pdf |
| 03/31/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1998 | SUPPL-16 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s016_Aredia_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s016.cfm |
| 09/22/1998 | SUPPL-15 | Labeling |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s015_Aredia_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20036s015_Aredia.cfm |
| 09/10/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1996 | SUPPL-11 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/01/1995 | SUPPL-9 | Efficacy-New Indication |
Label is not available on this site. |
||
| 12/08/1994 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/1994 | SUPPL-7 | Efficacy-New Indication |
Label is not available on this site. |
||
| 04/17/1995 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/09/1993 | SUPPL-5 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s001,002,005_ltr_lbl.pdf |
| 04/15/1994 | SUPPL-4 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/pre96/20-036s004_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s004_pkg.pdf | |
| 07/21/1992 | SUPPL-3 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s003_ltr_lbl.pdf |
| 05/06/1993 | SUPPL-2 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s001,002,005_ltr_lbl.pdf |
| 05/06/1993 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20-036s001,002,005_ltr_lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/31/2012 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020036s041lbl.pdf | |
| 04/07/2011 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020036s039lbl.pdf | |
| 12/12/2008 | SUPPL-35 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020036s035lbl.pdf | |
| 12/11/2007 | SUPPL-34 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020036s034lbl.pdf | |
| 11/16/2005 | SUPPL-32 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s032lbl.pdf | |
| 10/11/2005 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020036s031lbl.pdf | |
| 02/02/2005 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20036s030lbl.pdf | |
| 08/20/2001 | SUPPL-24 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20036s24lbl.pdf | |
| 04/15/1994 | SUPPL-4 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20036lbl.pdf | |
| 10/31/1991 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/20-036_aredia_lbl.pdf |