Application 018206
- Type
- NDA
- Sponsor
- CADENCE HEALTH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LO/OVRAL FE | ETHINYL ESTRADIOL; LEVONORGESTREL; FERROUS FUMARATE | TABLET;ORAL | 0.03MG,0.3MG;0.75MG | No | No |
Source provenance: Browse the complete Orange Book source catalog.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 70919 | SUPPL | 2022-05-03 |
| 70911 | SUPPL | 2022-05-03 |
| 50181 | SUPPL | 2017-10-25 |
| 50102 | SUPPL | 2017-10-19 |
| 49389 | SUPPL | 2017-08-15 |
| 49314 | SUPPL | 2017-08-10 |