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New Drug Application (NDA): 019787
Company: VIATRIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORVASC AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription AB Yes No
NORVASC AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription AB Yes No
NORVASC AMLODIPINE BESYLATE EQ 10MG 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
07/31/1992 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2017 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019787s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019787Orig1s062ltr.pdf
03/30/2017 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019787s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019787Orig1s061ltr.pdf
03/23/2015 SUPPL-59 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019787s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019787Orig1s059ltr.pdf
07/28/2014 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

07/24/2013 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

09/12/2013 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

11/16/2012 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

01/07/2013 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019787s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019787Orig1s053,s054ltr.pdf
01/07/2013 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019787s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019787Orig1s053,s054ltr.pdf
10/31/2011 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019787s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019787s052ltr.pdf
05/09/2011 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019787s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019787s047ltr.pdf
02/17/2010 SUPPL-45 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019787s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019787s045ltr.pdf
10/31/2007 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019787s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019787s042ltr.pdf
09/28/2005 SUPPL-38 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019787s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019787s038ltr.pdf
07/13/2005 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019787s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019787s037ltr.pdf
05/28/2002 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19787s032ltr.pdf
08/20/2003 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19787slr031ltr.pdf
01/08/2004 SUPPL-30 Efficacy-New Patient Population Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19787se5-030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019787_S30_NorvascTOC.cfm
08/13/2001 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/10/2001 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/03/2003 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19787slr027ltr.pdf
02/23/2000 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/06/2000 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/2000 SUPPL-23 Labeling

Label is not available on this site.

12/15/1999 SUPPL-22 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19787s022_Norvasc.pdf
02/01/2000 SUPPL-21 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19787s021_norvasc.pdf
07/12/2000 SUPPL-20 Efficacy-Labeling Change With Clinical Data Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19787S020LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19787-s017_norvase.pdf
09/07/1999 SUPPL-19 Manufacturing (CMC) Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19787S019_NORVASC_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019787-S19_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm
06/04/1999 SUPPL-18 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19787-s018_Norvasc.pdf
07/12/2000 SUPPL-17 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19787S020LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19787-s017_norvase.pdf
03/09/1998 SUPPL-16 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019787-S16_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm
05/16/1997 SUPPL-15 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019787-S15_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm
04/18/1997 SUPPL-14 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019787-S14_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm
01/08/1997 SUPPL-13 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/19787-S013_Norvasc.pdf
06/28/1996 SUPPL-12 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019787-S12_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm
02/07/1996 SUPPL-11 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019787-S11_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm
02/08/1996 SUPPL-10 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019787-S10_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm
12/05/1995 SUPPL-9 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S9_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm
11/02/1995 SUPPL-8 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S8_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm
06/14/1996 SUPPL-7 Efficacy-New Patient Population Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/19-787s007_Amlodipine.cfm
06/19/1995 SUPPL-6 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S6_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm
02/07/1995 SUPPL-5 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S5_Norvasc 2.5 mg, 5.0 mg, & 10.0 mg Tablets_toc.cfm
05/03/1994 SUPPL-4 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S4_Norvasc Tablets_toc.cfm
03/03/1994 SUPPL-3 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S3_Norvasc_toc.cfm
01/12/1995 SUPPL-2 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019787-S2_Norvasc Tablets_toc.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/30/2017 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019787s062lbl.pdf
03/30/2017 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019787s061lbl.pdf
03/23/2015 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019787s059lbl.pdf
01/07/2013 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019787s054lbl.pdf
01/07/2013 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019787s053lbl.pdf
10/31/2011 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019787s052lbl.pdf
05/09/2011 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019787s047lbl.pdf
02/17/2010 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019787s045lbl.pdf
10/31/2007 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019787s042lbl.pdf
09/28/2005 SUPPL-38 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019787s038lbl.pdf
07/13/2005 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019787s037lbl.pdf

NORVASC

TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 202553 ACCORD HLTHCARE
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078925 ALKEM
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078021 AUROBINDO PHARMA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 076692 CHARTWELL RX
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 090752 CHINA RESOURCES
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 077073 CIPLA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 076719 COREPHARMA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078552 EPIC PHARMA LLC
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 077955 INVAGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 206367 INVAGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078453 ORBION PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078414 OXFORD PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 207821 POLYGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 077516 STRIDES PHARMA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 076846 TEVA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 203245 UNICHEM
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 078226 ZYDUS PHARMS USA
NORVASC AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription Yes AB 019787 VIATRIS

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 202553 ACCORD HLTHCARE
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078925 ALKEM
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078021 AUROBINDO PHARMA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 076692 CHARTWELL RX
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 090752 CHINA RESOURCES
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077073 CIPLA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 076719 COREPHARMA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078552 EPIC PHARMA LLC
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077955 INVAGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 206367 INVAGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078453 ORBION PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078414 OXFORD PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 207821 POLYGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077516 STRIDES PHARMA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 076846 TEVA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 203245 UNICHEM
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078226 ZYDUS PHARMS USA
NORVASC AMLODIPINE BESYLATE EQ 5MG BASE TABLET;ORAL Prescription Yes AB 019787 VIATRIS

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 202553 ACCORD HLTHCARE
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078925 ALKEM
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078021 AUROBINDO PHARMA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 076692 CHARTWELL RX
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 090752 CHINA RESOURCES
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077073 CIPLA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 076719 COREPHARMA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078552 EPIC PHARMA LLC
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077955 INVAGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 206367 INVAGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078453 ORBION PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078414 OXFORD PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 207821 POLYGEN PHARMS
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077516 STRIDES PHARMA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 076846 TEVA
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 203245 UNICHEM
AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078226 ZYDUS PHARMS USA
NORVASC AMLODIPINE BESYLATE EQ 10MG BASE TABLET;ORAL Prescription Yes AB 019787 VIATRIS
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