Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018147
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FELDENE | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| FELDENE | PIROXICAM | 20MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 04/06/1982 | 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-52 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018147_S052LBL.pdf | |
| 04/28/2021 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018147Orig1s050ltr.pdf | |
| 05/03/2019 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018147s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018147Orig1s048ltr.pdf | |
| 05/09/2016 | SUPPL-44 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018147Orig1s044ltr.pdf | |
| 02/27/2015 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf | |
| 06/19/2013 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/2015 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf | |
| 02/27/2015 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf | |
| 02/27/2015 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf | |
| 02/27/2015 | SUPPL-33 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018147Orig1s033,s038,s039,s040,s042ltr.pdf | |
| 08/13/2010 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018147s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018147s032ltr.pdf | |
| 07/05/2007 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018147s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018147s030_ltr.pdf | |
| 01/24/2006 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018147s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018147s029ltr.pdf | |
| 01/08/2003 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18147slr028ltr.pdf |
| 03/09/2000 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/14/1998 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 09/14/1993 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1994 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1998 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/16/1989 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1998 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/24/1988 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/23/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1998 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/23/1986 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1985 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/10/1984 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 11/19/1984 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/17/1984 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/10/1984 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/17/1984 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/21/1983 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/03/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1983 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/22/1983 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/13/1983 | SUPPL-2 | Manufacturing (CMC) |
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-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018147_S052LBL.pdf | |
| 04/28/2021 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf | |
| 05/03/2019 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018147s048lbl.pdf | |
| 05/09/2016 | SUPPL-44 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf | |
| 05/09/2016 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf | |
| 05/09/2016 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf | |
| 02/27/2015 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf | |
| 02/27/2015 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf | |
| 02/27/2015 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf | |
| 02/27/2015 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf | |
| 02/27/2015 | SUPPL-33 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf | |
| 08/13/2010 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018147s032lbl.pdf | |
| 07/05/2007 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018147s030lbl.pdf | |
| 01/24/2006 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018147s029lbl.pdf |
FELDENE
CAPSULE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FELDENE | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | Yes | AB | 018147 | PFIZER |
| PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 206152 | MICRO LABS |
| PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 074118 | NOSTRUM LABS INC |
| PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 206136 | STRIDES PHARMA |
| PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 210347 | STRIDES PHARMA |
| PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 074131 | TEVA |
| PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 208340 | UNICHEM |
| PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Prescription | No | AB | 205585 | ZYDUS LIFESCIENCES |
CAPSULE;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FELDENE | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | Yes | AB | 018147 | PFIZER |
| PIROXICAM | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | No | AB | 206152 | MICRO LABS |
| PIROXICAM | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | No | AB | 074118 | NOSTRUM LABS INC |
| PIROXICAM | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | No | AB | 206136 | STRIDES PHARMA |
| PIROXICAM | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | No | AB | 210347 | STRIDES PHARMA |
| PIROXICAM | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | No | AB | 074131 | TEVA |
| PIROXICAM | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | No | AB | 208340 | UNICHEM |
| PIROXICAM | PIROXICAM | 20MG | CAPSULE;ORAL | Prescription | No | AB | 205585 | ZYDUS LIFESCIENCES |