Application 017802
- Type
- NDA
- Sponsor
- WYETH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LO/OVRAL-28 | ETHINYL ESTRADIOL; NORGESTREL | TABLET;ORAL-28 | 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 70908 | SUPPL | 2022-05-02 |
| 70876 | SUPPL | 2022-05-02 |
| 58688 | SUPPL | 2019-05-14 |
| 58647 | SUPPL | 2019-05-13 |
| 53487 | SUPPL | 2018-03-28 |
| 53251 | SUPPL | 2018-03-23 |
| 49390 | SUPPL | 2017-08-15 |
| 49310 | SUPPL | 2017-08-10 |
| 48687 | SUPPL | 2017-06-09 |
| 48683 | SUPPL | 2017-06-09 |
| 47566 | SUPPL | 2017-03-15 |
| 40759 | SUPPL | 2003-02-05 |