Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020560
Company: ORGANON
Company: ORGANON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FOSAMAX | ALENDRONATE SODIUM | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| FOSAMAX | ALENDRONATE SODIUM | EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| FOSAMAX | ALENDRONATE SODIUM | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| FOSAMAX | ALENDRONATE SODIUM | EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| FOSAMAX | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/29/1995 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020560Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/16/2019 | SUPPL-70 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020560s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020560Orig1s070ltr.pdf | |
| 11/30/2015 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s069,021575s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020560Orig1s069,021575Orig1s025ltr.pdf | |
| 04/08/2015 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020560Orig1s068,021575Orig1s024ltr.pdf | |
| 06/19/2015 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/2013 | SUPPL-66 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s066,021575s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020560Orig1s066;021575Orig1s023ltr.pdf | |
| 04/19/2013 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s065,021575s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020560Orig1s065,021575Orig1s022ltr.pdf | |
| 06/27/2012 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020560s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020560s062ltr.pdf | |
| 07/01/2011 | SUPPL-61 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020560s061,021575s021ltr.pdf |
| 01/25/2011 | SUPPL-60 | REMS |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020560s060,021575s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020560s060,021575s020ltr.pdf | |
| 03/01/2010 | SUPPL-57 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf | |
| 02/06/2012 | SUPPL-56 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020560s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020560s056,021575s017ltr.pdf | |
| 03/01/2010 | SUPPL-55 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf | |
| 10/08/2008 | SUPPL-52 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020560s052,021575s013,021762s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020560s052, 021575s013, 021762s006ltr.pdf | |
| 03/01/2010 | SUPPL-51 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf | |
| 12/28/2006 | SUPPL-48 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf | |
| 12/28/2006 | SUPPL-47 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf | |
| 11/02/2005 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021575s009,020560s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020560s046,021575s009ltr.pdf | |
| 12/01/2004 | SUPPL-44 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560s043,044,21575s005,006ltr.pdf | |
| 12/01/2004 | SUPPL-43 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560s043,044,21575s005,006ltr.pdf | |
| 02/20/2004 | SUPPL-42 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr042,21517slr003_fosamax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560slr042,21517slr003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020560_S042 & 021575_S003_FOSAMAX_TABS_ORAL_SOLUTION_AP.pdf | |
| 04/16/2004 | SUPPL-41 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560se8-041,21575slr004_fosamax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560se8-041,21575slr004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020560_s041_FOSAMAX TABS.pdf | |
| 09/17/2003 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20560slr040_fosamax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20560slr040ltr.pdf | |
| 12/21/2005 | SUPPL-38 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020560s038_021575s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020560s038,021575s007ltr.pdf | |
| 03/24/2003 | SUPPL-37 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20560slr037ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020560_s037_FOSAMAX TABS.pdf |
| 08/05/2002 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20560s36lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20560scp036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020560_s036_FOSAMAX_TABLETS.pdf | |
| 08/13/2002 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20560scp033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020560_s033_FOSAMAX TABS.pdf |
| 11/27/2001 | SUPPL-32 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020560_s032_FOSAMAX_TABLETS.pdf |
| 07/25/2002 | SUPPL-31 | Labeling |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20560s31lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020560_s031_FOSAMAX_TABLETS.pdf | |
| 04/27/2004 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr030,21575slr002_fosamax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560slr030,21575slr002ltr.pdf | |
| 06/26/2001 | SUPPL-29 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020560_S029_FOSAMAX.pdf |
| 09/16/2002 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20560s28lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20560slr028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020560_s028_FOSAMAX TABS.pdf | |
| 01/31/2001 | SUPPL-25 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20560lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20560LTR.pdf | |
| 01/31/2001 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20560lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20560LTR.pdf | |
| 09/29/2000 | SUPPL-23 | Efficacy-New Indication |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20563S23ltr.pdf |
| 10/20/2000 | SUPPL-22 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20560s21s22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20560S21ltr.pdf | |
| 10/20/2000 | SUPPL-21 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20560s21s22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20560S21ltr.pdf | |
| 10/19/1999 | SUPPL-20 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560_S020_FOSAMAX.pdf |
| 05/28/1999 | SUPPL-19 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560_S019_FOSAMAX_TABLETS.pdf |
| 11/24/1999 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20560S15LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20560S18_fosamax.cfm |
| 10/19/1999 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560_S016_FOSAMAX.pdf |
| 11/24/1999 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20560S15LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20560S15_fosamax.cfm |
| 03/19/1999 | SUPPL-14 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560_S014_FOSAMAX TABLETS.pdf |
| 06/08/1999 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S13_Fosamax_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S13_Fosamax_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S13_Fosamax.cfm | |
| 06/16/1999 | SUPPL-12 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20560s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20560s12ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S12_Fosamax.cfm | |
| 05/12/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 01/27/1998 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/24/1997 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/25/1997 | SUPPL-6 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20560ap_s03_s06.pdf |
| 11/21/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/25/1997 | SUPPL-3 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20560ap_s03_s06.pdf |
| 12/03/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/16/1995 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/16/2019 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020560s070lbl.pdf | |
| 11/30/2015 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s069,021575s025lbl.pdf | |
| 04/08/2015 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf | |
| 12/23/2013 | SUPPL-66 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s066,021575s023lbl.pdf | |
| 12/23/2013 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s066,021575s023lbl.pdf | |
| 04/19/2013 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s065,021575s022lbl.pdf | |
| 06/27/2012 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020560s062lbl.pdf | |
| 02/06/2012 | SUPPL-56 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020560s056lbl.pdf | |
| 01/25/2011 | SUPPL-60 | REMS | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020560s060,021575s020lbl.pdf | |
| 03/01/2010 | SUPPL-57 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf | |
| 03/01/2010 | SUPPL-55 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf | |
| 03/01/2010 | SUPPL-51 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf | |
| 10/08/2008 | SUPPL-52 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020560s052,021575s013,021762s006lbl.pdf | |
| 12/28/2006 | SUPPL-48 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf | |
| 12/28/2006 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf | |
| 12/21/2005 | SUPPL-38 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020560s038_021575s007lbl.pdf | |
| 11/02/2005 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021575s009,020560s046lbl.pdf | |
| 12/01/2004 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf | |
| 12/01/2004 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf | |
| 04/27/2004 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr030,21575slr002_fosamax_lbl.pdf | |
| 04/16/2004 | SUPPL-41 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560se8-041,21575slr004_fosamax_lbl.pdf | |
| 02/20/2004 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr042,21517slr003_fosamax_lbl.pdf | |
| 09/17/2003 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20560slr040_fosamax_lbl.pdf | |
| 09/16/2002 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20560s28lbl.pdf | |
| 08/05/2002 | SUPPL-36 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20560s36lbl.pdf | |
| 07/25/2002 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20560s31lbl.pdf | |
| 01/31/2001 | SUPPL-25 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20560lbl.pdf | |
| 01/31/2001 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20560lbl.pdf | |
| 10/20/2000 | SUPPL-22 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20560s21s22lbl.pdf | |
| 10/20/2000 | SUPPL-21 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20560s21s22lbl.pdf | |
| 06/16/1999 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20560s12lbl.pdf | |
| 06/08/1999 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020560S13_Fosamax_prntlbl.pdf |
FOSAMAX
TABLET;ORAL; EQ 70MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | No | AB | 077982 | APOTEX |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | No | AB | 090124 | AUROBINDO PHARMA |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | No | AB | 076768 | CIPLA |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | No | AB | 090258 | HANGZHOU BINJIANG |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | No | AB | 206387 | IPCA LABS LTD |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | No | AB | 090022 | SUN PHARM |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | No | AB | 076984 | WATSON LABS |
| FOSAMAX | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020560 | ORGANON |