Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018063
Company: US WORLDMEDS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORGARD NADOLOL 40MG TABLET;ORAL Prescription AB Yes No
CORGARD NADOLOL 80MG TABLET;ORAL Prescription AB Yes Yes
CORGARD NADOLOL 120MG TABLET;ORAL Discontinued None No No
CORGARD NADOLOL 160MG TABLET;ORAL Discontinued None No No
CORGARD NADOLOL 20MG TABLET;ORAL Prescription AB Yes 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
12/10/1979 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
07/15/2013 SUPPL-63 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018063s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018063Orig1s063ltr.pdf
06/06/2011 SUPPL-62 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018063s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018063s062ltr.pdf
02/04/2008 SUPPL-60 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018063s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018063s060ltr.pdf
09/19/2001 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

03/18/1996 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

08/16/1995 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

04/05/1994 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

05/01/1992 SUPPL-54 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/20/1992 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

11/08/1991 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

05/03/1991 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1991 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

11/07/1990 SUPPL-49 Labeling

Label is not available on this site.

09/03/1987 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/21/1990 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

01/06/1987 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/11/1987 SUPPL-45 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/19/1986 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1986 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1985 SUPPL-40 Labeling

Label is not available on this site.

10/24/1984 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/06/1984 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1984 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1984 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

10/28/1986 SUPPL-35 Efficacy-New Dosing Regimen

Label is not available on this site.

05/16/1984 SUPPL-34 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/06/1984 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/08/1984 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/17/1984 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/1984 SUPPL-30 Efficacy

Label is not available on this site.

11/01/1983 SUPPL-29 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/14/1983 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1983 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1983 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1983 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

11/18/1982 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/22/1982 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/01/1982 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/1982 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1982 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1982 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/1981 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/28/1981 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1981 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/09/1981 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/02/1981 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1981 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/27/1981 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/17/1981 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/1980 SUPPL-8 Labeling

Label is not available on this site.

10/22/1980 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/1981 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/14/1980 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/11/1980 SUPPL-2 Labeling

Label is not available on this site.

02/11/1980 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/15/2013 SUPPL-63 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018063s063lbl.pdf
06/06/2011 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018063s062lbl.pdf
02/04/2008 SUPPL-60 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018063s060lbl.pdf

CORGARD

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

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 074229 HERITAGE PHARMA
NADOLOL NADOLOL 20MG TABLET;ORAL Prescription No AB 203455 INVAGEN 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

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