Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074229
Company: IVAX SUB TEVA PHARMS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/30/1996 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; 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 USA INC

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 USA INC

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