Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020607
Company: PFIZER
Company: PFIZER
| 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 |
|---|---|---|---|---|---|
| 12/22/2022 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020607s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020607Orig1s041ltr.pdf | |
| 08/26/2022 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020607s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020607Orig1s040ltr.pdf | |
| 08/02/2021 | SUPPL-39 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020607s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020607Orig1s039ltr.pdf | |
| 04/28/2021 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020607s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020607Orig1s038ltr.pdf | |
| 09/24/2020 | SUPPL-36 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020607Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020607Orig1s036ltr.pdf | |
| 07/28/2020 | SUPPL-33 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020607Orig1s033ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 12/22/2022 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020607s041lbl.pdf | |
| 08/26/2022 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020607s040lbl.pdf | |
| 08/02/2021 | SUPPL-39 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020607s039lbl.pdf | |
| 08/02/2021 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020607s039lbl.pdf | |
| 04/28/2021 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020607s038lbl.pdf | |
| 09/24/2020 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020607Orig1s036lbl.pdf | |
| 09/24/2020 | SUPPL-36 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020607Orig1s036lbl.pdf | |
| 09/24/2020 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020607Orig1s036lbl.pdf | |
| 07/28/2020 | SUPPL-33 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s033lbl.pdf | |
| 07/28/2020 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020406s033lbl.pdf | |
| 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 | PFIZER |
| 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 | 204355 | MICRO LABS |
| DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 200158 | SANDOZ |
| DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 205143 | YUNG SHIN PHARM |
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 | PFIZER |
| 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 | 204355 | MICRO LABS |
| DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 200158 | SANDOZ |
| DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 205143 | YUNG SHIN PHARM |