Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018647
Company: KING PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORZIDE BENDROFLUMETHIAZIDE; NADOLOL 5MG;40MG TABLET;ORAL Prescription AB Yes No
CORZIDE BENDROFLUMETHIAZIDE; NADOLOL 5MG;80MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/25/1983 ORIG-1 Approval Type 4 - New Combination STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18-647_corzide.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/15/2013 SUPPL-25 Labeling, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018647s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018647Orig1s025ltr.pdf
06/06/2011 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018647s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018647s024ltr.pdf
08/12/2008 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018647s020ltr.pdf
05/30/2003 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18647slr016ltr.pdf
05/07/2002 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/06/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/11/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/18/1996 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1992 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/28/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/05/1990 SUPPL-9 Labeling

Label is not available on this site.

08/09/1990 SUPPL-8 Labeling

Label is not available on this site.

03/04/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/22/1989 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/06/1987 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/22/1985 SUPPL-4 Labeling

Label is not available on this site.

04/25/1985 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/06/1984 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/06/1984 SUPPL-1 Manufacturing (CMC)-Packaging

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-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018647s025lbl.pdf
07/15/2013 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018647s025lbl.pdf
06/06/2011 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018647s024lbl.pdf

CORZIDE

TABLET;ORAL; 5MG;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORZIDE BENDROFLUMETHIAZIDE; NADOLOL 5MG;40MG TABLET;ORAL Prescription Yes AB 018647 KING PHARMS LLC
NADOLOL AND BENDROFLUMETHIAZIDE BENDROFLUMETHIAZIDE; NADOLOL 5MG;40MG TABLET;ORAL Prescription No AB 077833 IMPAX LABS

TABLET;ORAL; 5MG;80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CORZIDE BENDROFLUMETHIAZIDE; NADOLOL 5MG;80MG TABLET;ORAL Prescription Yes AB 018647 KING PHARMS LLC
NADOLOL AND BENDROFLUMETHIAZIDE BENDROFLUMETHIAZIDE; NADOLOL 5MG;80MG TABLET;ORAL Prescription No AB 077833 IMPAX LABS

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