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New Drug Application (NDA): 020560
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FOSAMAX ALENDRONATE SODIUM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
FOSAMAX ALENDRONATE SODIUM EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
FOSAMAX ALENDRONATE SODIUM EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
FOSAMAX ALENDRONATE SODIUM EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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
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