Application 018147
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | FELDENE | PIROXICAM | CAPSULE;ORAL | 10MG | Yes | No |
| 003 | FELDENE | PIROXICAM | CAPSULE;ORAL | 20MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-3220 | Feldene | piroxicam | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3220 | Feldene | piroxicam | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3220 | Feldene | piroxicam | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3220 | Feldene | piroxicam | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3220 | Feldene | piroxicam | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3230 | Feldene | piroxicam | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3230 | Feldene | piroxicam | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3230 | Feldene | piroxicam | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3230 | Feldene | piroxicam | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-3230 | Feldene | piroxicam | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 59762-0140 | Piroxicam | piroxicam | Greenstone LLC | NDA | Current |
| 59762-0140 | Piroxicam | piroxicam | Greenstone LLC | NDA | Current |
| 59762-0140 | Piroxicam | piroxicam | Greenstone LLC | NDA | Current |
| 59762-0140 | Piroxicam | piroxicam | Greenstone LLC | NDA | Current |
| 59762-0145 | Piroxicam | piroxicam | Greenstone LLC | NDA | Current |
| 59762-0145 | Piroxicam | piroxicam | Greenstone LLC | NDA | Current |
| 59762-0145 | Piroxicam | piroxicam | Greenstone LLC | NDA | Current |
| 59762-0145 | Piroxicam | piroxicam | Greenstone LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80368 | SUPPL | 2024-11-25 |
| 80367 | SUPPL | 2024-11-25 |
| 80275 | SUPPL | 2024-11-22 |
| 72693 | SUPPL | 2022-11-24 |
| 67291 | SUPPL | 2021-04-30 |
| 67286 | SUPPL | 2021-04-30 |
| 67229 | SUPPL | 2021-04-29 |
| 58584 | SUPPL | 2019-05-06 |
| 58583 | SUPPL | 2019-05-06 |
| 58570 | SUPPL | 2019-05-06 |
| 56346 | SUPPL | 2018-11-08 |
| 33444 | SUPPL | 2016-05-11 |
| 855 | SUPPL | 2016-05-11 |
| 33443 | SUPPL | 2015-03-04 |
| 33442 | SUPPL | 2015-03-04 |
| 11172 | SUPPL | 2015-03-04 |
| 11171 | SUPPL | 2015-03-04 |
| 11170 | SUPPL | 2015-03-04 |
| 14923 | SUPPL | 2015-03-02 |
| 14922 | SUPPL | 2015-03-02 |
| 14921 | SUPPL | 2015-03-02 |
| 854 | SUPPL | 2015-03-02 |
| 853 | SUPPL | 2015-03-02 |
| 852 | SUPPL | 2010-09-07 |
| 11169 | SUPPL | 2010-08-28 |
| 14920 | SUPPL | 2007-07-10 |
| 33441 | SUPPL | 2007-07-06 |
| 14919 | SUPPL | 2006-01-30 |
| 11168 | SUPPL | 2006-01-25 |
| 14918 | SUPPL | 2004-06-04 |