TRUQAP
NDA 218197 · New Drug Application (NDA) Prescription
CAPIVASERTIB
- Sponsor (Drugs@FDA)
- ASTRAZENECA Company: ASTRAZENECA PLC (AZN)
- First approved
- Latest action
Drugs on HealthTrade
Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | TRUQAP CAPIVASERTIB | TABLET;ORAL 160MG | Prescription | – | Reference listed drug | RXApproved |
| 002 | TRUQAP CAPIVASERTIB | TABLET;ORAL 200MG | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 6 | Approved | standard | Efficacy | Letter for Supplement 6 (opens in a new tab)Label for Supplement 6 (opens in a new tab) | |
| Supplement 4 | Approved | standard | Efficacy | Letter for Supplement 4 (opens in a new tab)Label for Supplement 4 (opens in a new tab) | |
| Supplement 5 | Approved | standard | Labeling | Letter for Supplement 5 (opens in a new tab) | |
| Supplement 3 | Approved | standard | Labeling | Letter for Supplement 3 (opens in a new tab)Label for Supplement 3 (opens in a new tab) | |
| Supplement 2 | Approved | standard | Labeling | Letter for Supplement 2 (opens in a new tab)Label for Supplement 2 (opens in a new tab) | |
| Supplement 1 | Approved | standard | Labeling | Letter for Supplement 1 (opens in a new tab)Label for Supplement 1 (opens in a new tab) | |
| Original 1 | Approved | priority | Type 1 - New Molecular Entity | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
20 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 10059714Product 001 | Drug substance, Drug product | – | ||
| 10654855Product 001 | Method of use | U-3762 | ||
| 11236095Product 001 | Method of use | U-4559 | ||
| 11760760Product 001 | Method of use | U-3762 | ||
| 12252495Product 001 | Method of use | U-3762 | ||
| 9492453Product 001 | Method of use | U-4559 | ||
| 8101623Product 001 | Drug substance, Drug product | U-3762 | ||
| 9487525Product 001 | Drug substance, Drug product | – | ||
| 10039766Product 001 | Method of use | U-3762 | ||
| 10039766Product 001 | Method of use | U-4559 | ||
| 10059714Product 002 | Drug substance, Drug product | – | ||
| 10654855Product 002 | Method of use | U-3762 | ||
| 11236095Product 002 | Method of use | U-4559 | ||
| 11760760Product 002 | Method of use | U-3762 | ||
| 12252495Product 002 | Method of use | U-3762 | ||
| 9492453Product 002 | Method of use | U-4559 | ||
| 8101623Product 002 | Drug substance, Drug product | U-3762 | ||
| 9487525Product 002 | Drug substance, Drug product | – | ||
| 10039766Product 002 | Method of use | U-3762 | ||
| 10039766Product 002 | Method of use | U-4559 |
Orange Book exclusivities
| Code | Product | Expires |
|---|---|---|
| NCE | 001 | |
| I-991 | 001 | |
| NCE | 002 | |
| I-991 | 002 |
Codes as the Orange Book prints them; its preface explains each code.
Prescription labels
No human prescription label in openFDA cites this application.
NDC products
2 products in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 0310-9500 in openFDA (opens in a new tab) | TRUQAP capivasertib | AstraZeneca Pharmaceuticals LP | TABLET, FILM COATED ORAL | NDA | From |
| 0310-9501 in openFDA (opens in a new tab) | TRUQAP capivasertib | AstraZeneca Pharmaceuticals LP | TABLET, FILM COATED ORAL | NDA | From |
FDA recalls load here.
FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-10-25.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-10-25.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-10-25.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.