Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020607
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARTHROTEC DICLOFENAC SODIUM; MISOPROSTOL 50MG;0.2MG TABLET, DELAYED RELEASE;ORAL Prescription AB Yes No
ARTHROTEC DICLOFENAC SODIUM; MISOPROSTOL 75MG;0.2MG TABLET, DELAYED RELEASE;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
12/24/1997 ORIG-1 Approval Type 4 - New Combination STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020607_arthrotec_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2016 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020607s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020607Orig1s031ltr.pdf
09/03/2014 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020607s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020607Orig1s028ltr.pdf
02/08/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/07/2013 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020607s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020607Orig1s025ltr.pdf
04/01/2015 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020607s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020607Orig1s021ltr.pdf
12/21/2010 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020607s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020607s016ltr.pdf
02/25/2009 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020607s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020607s014ltr.pdf
09/11/2009 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020607s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020607s013ltr.pdf
08/24/2007 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020607s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020607s010ltr.pdf
01/25/2006 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020607s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020607s009ltr.pdf
07/08/2005 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020607s008ltr.pdf
05/20/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/03/2000 SUPPL-5 Labeling

Label is not available on this site.

02/22/1999 SUPPL-4 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20607s4.pdf
07/20/1998 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1998 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/15/1998 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
05/09/2016 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020607s031lbl.pdf
04/01/2015 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020607s021lbl.pdf
09/03/2014 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020607s028lbl.pdf
03/07/2013 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020607s025lbl.pdf
12/21/2010 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020607s016lbl.pdf
09/11/2009 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020607s013lbl.pdf
02/25/2009 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020607s014lbl.pdf
08/24/2007 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020607s010lbl.pdf
01/25/2006 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020607s009lbl.pdf

ARTHROTEC

TABLET, DELAYED RELEASE;ORAL; 50MG;0.2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARTHROTEC DICLOFENAC SODIUM; MISOPROSTOL 50MG;0.2MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 020607 GD SEARLE LLC
DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL 50MG;0.2MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 201089 ACTAVIS LABS FL INC
DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL 50MG;0.2MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 203995 AMNEAL PHARMS
DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL 50MG;0.2MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 200540 EXELA HOLDINGS
DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL 50MG;0.2MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 200158 SANDOZ

TABLET, DELAYED RELEASE;ORAL; 75MG;0.2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARTHROTEC DICLOFENAC SODIUM; MISOPROSTOL 75MG;0.2MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 020607 GD SEARLE LLC
DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL 75MG;0.2MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 201089 ACTAVIS LABS FL INC
DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL 75MG;0.2MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 203995 AMNEAL PHARMS
DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL 75MG;0.2MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 200540 EXELA HOLDINGS
DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL 75MG;0.2MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 200158 SANDOZ

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