Application 017970
- Type
- NDA
- Sponsor
- ASTRAZENECA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NOLVADEX | TAMOXIFEN CITRATE | TABLET;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | NOLVADEX | TAMOXIFEN CITRATE | TABLET;ORAL | EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 53729 | SUPPL | 2018-04-18 |
| 43602 | ORIG | 2009-11-19 |
| 40766 | SUPPL | 2009-09-14 |
| 768 | SUPPL | 2006-03-23 |
| 33386 | SUPPL | 2006-03-14 |
| 33385 | SUPPL | 2005-03-23 |
| 767 | SUPPL | 2005-03-23 |
| 11105 | SUPPL | 2004-12-30 |
| 766 | SUPPL | 2004-12-30 |
| 33384 | SUPPL | 2004-06-10 |
| 13972 | SUPPL | 2004-06-10 |
| 20100 | SUPPL | 2003-07-05 |
| 20099 | SUPPL | 2003-07-05 |
| 11103 | SUPPL | 2003-06-22 |
| 764 | SUPPL | 2003-06-22 |
| 40769 | SUPPL | 2003-03-07 |
| 13971 | SUPPL | 2002-08-30 |
| 11104 | SUPPL | 2002-08-30 |
| 33383 | SUPPL | 2002-05-16 |
| 33381 | SUPPL | 2002-05-16 |
| 13968 | SUPPL | 2002-05-16 |
| 11101 | SUPPL | 2002-05-16 |
| 765 | SUPPL | 2002-05-16 |
| 763 | SUPPL | 2002-05-16 |
| 40768 | SUPPL | 2000-06-29 |
| 33382 | SUPPL | 2000-06-29 |
| 13970 | SUPPL | 2000-06-29 |
| 40767 | SUPPL | 1998-10-29 |
| 33380 | SUPPL | 1998-10-29 |
| 20098 | SUPPL | 1998-10-29 |
| 13969 | SUPPL | 1998-10-29 |
| 11102 | SUPPL | 1998-10-29 |
| 762 | SUPPL | 1998-10-29 |