Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201893
Company: AUROBINDO PHARMA LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
09/16/2015 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201893Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/01/2019 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

NADOLOL

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 074229 HERITAGE PHARMA
NADOLOL NADOLOL 40MG TABLET;ORAL Prescription No AB 203455 INVAGEN 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 074255 HERITAGE PHARMA
NADOLOL NADOLOL 80MG TABLET;ORAL Prescription No AB 203455 INVAGEN 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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