Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018841
Company: PFIZER
Company: PFIZER
| 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 |
|---|---|---|---|---|---|
| 11/09/2022 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018841s034lbl.pdf | |
| 04/28/2021 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018841s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018841Orig1s033ltr.pdf | |
| 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-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
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 |
|---|---|---|---|---|---|
| 11/09/2022 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018841s034lbl.pdf | |
| 04/28/2021 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018841s033lbl.pdf | |
| 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-Medication Guide | 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-Package Insert | 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 | PFIZER |
| OXAPROZIN | OXAPROZIN | 600MG | TABLET;ORAL | Prescription | No | AB | 208633 | AMNEAL PHARMS CO |
| OXAPROZIN | OXAPROZIN | 600MG | TABLET;ORAL | Prescription | No | AB | 075987 | CHARTWELL |
| OXAPROZIN | OXAPROZIN | 600MG | TABLET;ORAL | Prescription | No | AB | 075855 | DR REDDYS LABS LTD |
| OXAPROZIN | OXAPROZIN | 600MG | TABLET;ORAL | Prescription | No | AB | 075845 | SANDOZ |