Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018841
Company: GD SEARLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAYPRO OXAPROZIN 600MG 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
10/29/1992 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
05/03/2019 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018841s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018841Orig1s030ltr.pdf
05/09/2016 SUPPL-28 Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018841s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018841Orig1s028ltr.pdf
06/21/2007 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/18841s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018841s022ltr.pdf
01/18/2006 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018841s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018841s021ltr.pdf
04/10/2003 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18841slr020_Daypro_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18841slr020ltr.pdf
09/08/2000 SUPPL-18 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/22/2000 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/25/2002 SUPPL-16 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18841s12s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18841s12s16ltr.pdf
01/06/1998 SUPPL-15 Labeling

Label is not available on this site.

01/06/1998 SUPPL-14 Labeling

Label is not available on this site.

01/25/2002 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18841s12s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18841s12s16ltr.pdf
05/08/1997 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/06/1998 SUPPL-9 Labeling

Label is not available on this site.

06/13/1996 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/06/1998 SUPPL-7 Labeling

Label is not available on this site.

09/10/1996 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1995 SUPPL-5 Labeling

Label is not available on this site.

02/22/1995 SUPPL-4 Labeling

Label is not available on this site.

11/03/1995 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/27/1993 SUPPL-2 Labeling

Label is not available on this site.

04/02/1993 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
05/03/2019 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018841s030lbl.pdf
05/09/2016 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018841s028lbl.pdf
05/09/2016 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018841s028lbl.pdf
05/09/2016 SUPPL-28 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018841s028lbl.pdf
06/21/2007 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/18841s022lbl.pdf
01/18/2006 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018841s021lbl.pdf
04/10/2003 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18841slr020_Daypro_lbl.pdf
01/25/2002 SUPPL-16 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18841s12s16lbl.pdf
01/25/2002 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18841s12s16lbl.pdf

DAYPRO

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DAYPRO OXAPROZIN 600MG TABLET;ORAL Prescription Yes AB 018841 GD SEARLE
OXAPROZIN OXAPROZIN 600MG TABLET;ORAL Prescription No AB 208633 AMNEAL PHARMS CO
OXAPROZIN OXAPROZIN 600MG TABLET;ORAL Prescription No AB 075987 APOTEX INC
OXAPROZIN OXAPROZIN 600MG TABLET;ORAL Prescription No AB 075855 DR REDDYS LABS LTD
OXAPROZIN OXAPROZIN 600MG TABLET;ORAL Prescription No AB 075846 IVAX SUB TEVA PHARMS
OXAPROZIN OXAPROZIN 600MG TABLET;ORAL Prescription No AB 075845 SANDOZ
OXAPROZIN OXAPROZIN 600MG TABLET;ORAL Prescription No AB 075849 TEVA

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