Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074501
Company: SANDOZ

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NADOLOL NADOLOL 20MG TABLET;ORAL Prescription AB No No
NADOLOL NADOLOL 40MG TABLET;ORAL Prescription AB No No
NADOLOL NADOLOL 80MG TABLET;ORAL Prescription AB 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
11/09/1995 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/13/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
07/29/2008 SUPPL-4 Labeling

Label is not available on this site.
01/03/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
01/03/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

NADOLOL

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORGARD NADOLOL 20MG TABLET;ORAL Prescription Yes AB 018063 US WORLDMEDS LLC
NADOLOL NADOLOL 20MG TABLET;ORAL Prescription No AB 208832 AMNEAL PHARMS CO
NADOLOL NADOLOL 20MG TABLET;ORAL Prescription No AB 210955 BEXIMCO PHARMS USA
NADOLOL NADOLOL 20MG TABLET;ORAL Prescription No AB 203455 INVAGEN PHARMS
NADOLOL NADOLOL 20MG TABLET;ORAL Prescription No AB 074229 IVAX SUB TEVA PHARMS
NADOLOL NADOLOL 20MG TABLET;ORAL Prescription No AB 209309 LUPIN LTD
NADOLOL NADOLOL 20MG TABLET;ORAL Prescription No AB 074172 MYLAN
NADOLOL NADOLOL 20MG TABLET;ORAL Prescription No AB 210786 NOVAST LABS
NADOLOL NADOLOL 20MG TABLET;ORAL Prescription No AB 074501 SANDOZ
NADOLOL NADOLOL 20MG TABLET;ORAL Prescription No AB 207761 ZYDUS PHARMS

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORGARD NADOLOL 40MG TABLET;ORAL Prescription Yes AB 018063 US WORLDMEDS LLC
NADOLOL NADOLOL 40MG TABLET;ORAL Prescription No AB 208832 AMNEAL PHARMS CO
NADOLOL NADOLOL 40MG TABLET;ORAL Prescription No AB 201893 AUROBINDO PHARMA LTD
NADOLOL NADOLOL 40MG TABLET;ORAL Prescription No AB 210955 BEXIMCO PHARMS USA
NADOLOL NADOLOL 40MG TABLET;ORAL Prescription No AB 203455 INVAGEN PHARMS
NADOLOL NADOLOL 40MG TABLET;ORAL Prescription No AB 074229 IVAX SUB TEVA PHARMS
NADOLOL NADOLOL 40MG TABLET;ORAL Prescription No AB 209309 LUPIN LTD
NADOLOL NADOLOL 40MG TABLET;ORAL Prescription No AB 074172 MYLAN
NADOLOL NADOLOL 40MG TABLET;ORAL Prescription No AB 210786 NOVAST LABS
NADOLOL NADOLOL 40MG TABLET;ORAL Prescription No AB 074501 SANDOZ
NADOLOL NADOLOL 40MG TABLET;ORAL Prescription No AB 207761 ZYDUS PHARMS

TABLET;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORGARD NADOLOL 80MG TABLET;ORAL Prescription Yes AB 018063 US WORLDMEDS LLC
NADOLOL NADOLOL 80MG TABLET;ORAL Prescription No AB 208832 AMNEAL PHARMS CO
NADOLOL NADOLOL 80MG TABLET;ORAL Prescription No AB 201893 AUROBINDO PHARMA LTD
NADOLOL NADOLOL 80MG TABLET;ORAL Prescription No AB 210955 BEXIMCO PHARMS USA
NADOLOL NADOLOL 80MG TABLET;ORAL Prescription No AB 203455 INVAGEN PHARMS
NADOLOL NADOLOL 80MG TABLET;ORAL Prescription No AB 074255 IVAX SUB TEVA PHARMS
NADOLOL NADOLOL 80MG TABLET;ORAL Prescription No AB 209309 LUPIN LTD
NADOLOL NADOLOL 80MG TABLET;ORAL Prescription No AB 074172 MYLAN
NADOLOL NADOLOL 80MG TABLET;ORAL Prescription No AB 210786 NOVAST LABS
NADOLOL NADOLOL 80MG TABLET;ORAL Prescription No AB 074501 SANDOZ
NADOLOL NADOLOL 80MG TABLET;ORAL Prescription No AB 207761 ZYDUS PHARMS

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