Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074255
Company: HERITAGE PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NADOLOL NADOLOL 80MG TABLET;ORAL Prescription AB No No
NADOLOL NADOLOL 120MG TABLET;ORAL Discontinued None No No
NADOLOL NADOLOL 160MG TABLET;ORAL Discontinued None 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
01/24/1996 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
04/16/2015 SUPPL-19 Labeling-Package Insert

Label is not available on this site.
04/16/2015 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
04/16/2015 SUPPL-16 Labeling

Label is not available on this site.
07/29/2002 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.
03/12/2002 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.
07/31/2001 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
01/28/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.
04/06/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
04/06/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

NADOLOL

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 USWM
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 074501 SANDOZ
NADOLOL NADOLOL 80MG TABLET;ORAL Prescription No AB 212856 VGYAAN
NADOLOL NADOLOL 80MG TABLET;ORAL Prescription No AB 207761 ZYDUS PHARMS

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