Application 019668
- Type
- NDA
- Sponsor
- PFIZER
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CARDURA | DOXAZOSIN MESYLATE | TABLET;ORAL | EQ 1MG BASE | Yes | Yes |
| 002 | CARDURA | DOXAZOSIN MESYLATE | TABLET;ORAL | EQ 2MG BASE | Yes | No |
| 003 | CARDURA | DOXAZOSIN MESYLATE | TABLET;ORAL | EQ 4MG BASE | Yes | No |
| 004 | CARDURA | DOXAZOSIN MESYLATE | TABLET;ORAL | EQ 8MG BASE | Yes | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0049-2410 | Cardura | doxazosin | Roerig | NDA | Current |
| 0049-2410 | Cardura | doxazosin | Roerig | NDA | Current |
| 0049-2410 | Cardura | doxazosin | Roerig | NDA | Current |
| 0049-2512 | Cardura | doxazosin | Roerig | NDA | Current |
| 0049-2512 | Cardura | doxazosin | Roerig | NDA | Current |
| 0049-2512 | Cardura | doxazosin | Roerig | NDA | Current |
| 0049-2614 | Cardura | doxazosin | Roerig | NDA | Current |
| 0049-2614 | Cardura | doxazosin | Roerig | NDA | Current |
| 0049-2614 | Cardura | doxazosin | Roerig | NDA | Current |
| 0049-2750 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2750 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2750 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2750 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2750 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2750 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2750 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2750 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2760 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2760 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2760 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2760 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2760 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2760 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2760 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2760 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2770 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2770 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2770 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2770 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2770 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2770 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2770 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2770 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2780 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2780 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2780 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2780 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2780 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2780 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2780 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 0049-2780 | Cardura | doxazosin mesylate | Roerig | NDA | Current |
| 59762-2310 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2310 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2310 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2310 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2310 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2310 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2310 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2310 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2310 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2320 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2320 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2320 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2320 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2320 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2320 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2320 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2320 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2320 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2340 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2340 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2340 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2340 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2340 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2340 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2340 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2340 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2340 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2380 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2380 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2380 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2380 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2380 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2380 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2380 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2380 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2380 | Doxazosin mesylate | doxazosin mesylate | Greenstone LLC | NDA | Current |
| 59762-2410 | Doxazosin | doxazosin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2410 | Doxazosin | doxazosin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-2410 | Doxazosin | doxazosin | Greenstone LLC | NDA | Current |
Documents
| Document | Title | Submission type | Submission no. | Date |
|---|
| 68463 | 0 | SUPPL | 32 | 2021-08-25 |
| 67895 | 0 | SUPPL | 32 | 2021-06-24 |
| 11617 | 0 | SUPPL | 28 | 2016-06-13 |
| 1482 | 0 | SUPPL | 28 | 2016-06-10 |
| 11615 | 0 | SUPPL | 22 | 2015-08-24 |
| 11616 | 0 | SUPPL | 26 | 2013-11-08 |
| 17541 | 0 | SUPPL | 26 | 2013-11-07 |
| 17540 | 0 | SUPPL | 22 | 2010-03-10 |
| 33850 | 0 | SUPPL | 21 | 2009-07-23 |
| 17539 | 0 | SUPPL | 21 | 2009-07-17 |
| 1481 | 0 | SUPPL | 17 | 2006-03-03 |
| 17538 | 0 | SUPPL | 12 | 2003-06-22 |
| 1480 | 0 | SUPPL | 15 | 2002-01-23 |