Application 206162
- Type
- NDA
- Sponsor
- ASTRAZENECA PHARMS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LYNPARZA | OLAPARIB | CAPSULE;ORAL | 50MG | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0310-0657 | Lynparza | olaparib | AstraZeneca Pharmaceuticals LP | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 59051 | SUPPL | 2019-06-13 |
| 55817 | SUPPL | 2018-10-04 |
| 55816 | SUPPL | 2018-10-04 |
| 55750 | SUPPL | 2018-10-01 |
| 50212 | SUPPL | 2017-10-30 |
| 50129 | SUPPL | 2017-10-23 |
| 50128 | SUPPL | 2017-10-23 |
| 49500 | SUPPL | 2017-08-22 |
| 49495 | SUPPL | 2017-08-21 |
| 47016 | SUPPL | 2017-01-30 |
| 46996 | SUPPL | 2017-01-26 |
| 45684 | SUPPL | 2016-10-28 |
| 45574 | SUPPL | 2016-10-20 |
| 32783 | ORIG | 2014-12-19 |
| 24511 | ORIG | 2014-12-19 |
| 23014 | ORIG | 2014-12-19 |
| 19707 | ORIG | 2014-12-19 |