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 |
Showing 1 to 2 of 2 entries
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes |
---|---|---|---|---|---|---|
12/24/1997 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Review
|
Label is not available on this site. |
Showing 1 to 1 of 1 entries
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note |
---|---|---|---|---|
11/21/2024 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
12/22/2022 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
08/26/2022 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
08/02/2021 | SUPPL-39 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
04/28/2021 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
09/24/2020 | SUPPL-36 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
07/28/2020 | SUPPL-33 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
|
05/09/2016 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
04/01/2015 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
|
09/03/2014 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
03/07/2013 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
|
02/08/2013 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
|
12/21/2010 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
|
09/11/2009 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
|
02/25/2009 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
|
08/24/2007 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
|
01/25/2006 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
|
07/08/2005 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
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. |
07/20/1998 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
|
04/15/1998 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
|
03/16/1998 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Showing 1 to 24 of 24 entries
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note |
---|---|---|---|---|
11/21/2024 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | |
12/22/2022 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | |
08/26/2022 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | |
08/02/2021 | SUPPL-39 | Labeling-Medication Guide | Label (PDF) | |
08/02/2021 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | |
04/28/2021 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | |
09/24/2020 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | |
09/24/2020 | SUPPL-36 | Labeling-Medication Guide | Label (PDF) | |
09/24/2020 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | |
07/28/2020 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | |
07/28/2020 | SUPPL-33 | Labeling-Medication Guide | Label (PDF) | |
05/09/2016 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | |
04/01/2015 | SUPPL-21 | Labeling | Label (PDF) | |
09/03/2014 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | |
03/07/2013 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | |
12/21/2010 | SUPPL-16 | Labeling | Label (PDF) | |
09/11/2009 | SUPPL-13 | Labeling | Label (PDF) | |
02/25/2009 | SUPPL-14 | Labeling | Label (PDF) | |
08/24/2007 | SUPPL-10 | Labeling | Label (PDF) | |
01/25/2006 | SUPPL-9 | Labeling | Label (PDF) |
Showing 1 to 20 of 20 entries
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 | 205143 | YUNG SHIN PHARM |
Showing 1 to 5 of 5 entries
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 | 205143 | YUNG SHIN PHARM |
Showing 1 to 5 of 5 entries