Application 018422
- Type
- NDA
- Sponsor
- PFIZER PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOPID | GEMFIBROZIL | CAPSULE;ORAL | 200MG | No | No |
| 002 | LOPID | GEMFIBROZIL | CAPSULE;ORAL | 300MG | No | No |
| 003 | LOPID | GEMFIBROZIL | TABLET;ORAL | 600MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0071-0737 | Lopid | gemfibrozil | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0737 | Lopid | gemfibrozil | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-0737 | Lopid | gemfibrozil | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 59762-0737 | Gemfibrozil | Gemfibrozil | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0737 | Gemfibrozil | Gemfibrozil | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0737 | Gemfibrozil | Gemfibrozil | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 70518-0687 | Lopid | gemfibrozil | REMEDYREPACK INC. | NDA | Current |
| 70518-0687 | Lopid | gemfibrozil | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 65586 | SUPPL | 2020-12-14 |
| 65574 | SUPPL | 2020-12-11 |
| 53870 | SUPPL | 2018-04-27 |
| 53819 | SUPPL | 2018-04-26 |
| 48067 | SUPPL | 2017-04-19 |
| 48064 | SUPPL | 2017-04-19 |
| 920 | SUPPL | 2016-04-08 |
| 33490 | SUPPL | 2016-04-07 |
| 11218 | SUPPL | 2014-11-07 |
| 919 | SUPPL | 2014-11-07 |
| 15001 | SUPPL | 2013-11-06 |
| 11217 | SUPPL | 2013-11-01 |
| 918 | SUPPL | 2010-09-29 |
| 11216 | SUPPL | 2010-09-27 |
| 11215 | SUPPL | 2009-07-17 |
| 917 | SUPPL | 2009-07-17 |
| 14999 | SUPPL | 2004-06-08 |
| 915 | SUPPL | 2004-06-08 |
| 916 | SUPPL | 2004-04-07 |
| 33489 | SUPPL | 2003-04-14 |
| 11214 | SUPPL | 2003-04-14 |
| 15000 | SUPPL | 2003-01-15 |