osimertinib Oral Tablet
- Brand(s)
- Tagrisso
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Astrazeneca Pharmaceuticals Lp (2015-11-13)
- Oldest Current Product
- 2015-11-13
- License(s)
- NDA
- RxNORM
- ORAL TABLET\OSIMERTINIB
- SPL Active
- ORAL\TABLET, FILM COATED\OSIMERTINIB
- SPL Moiety
- ORAL\TABLET, FILM COATED\OSIMERTINIB
product(s) by strength(s)
osimertinib 40 mg oral tablet
product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 003101349 | Tagrisso | NDA | Astrazeneca Pharmaceuticals Lp | 2015-11-13 | OSIMERTINIB | ORAL | TABLET, FILM COATED | NDA208065 | 5e81b4a7-b971-45e1-9c31-29cea8c87ce7 |
osimertinib 80 mg oral tablet
product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 003101350 | Tagrisso | NDA | Astrazeneca Pharmaceuticals Lp | 2015-11-13 | OSIMERTINIB | ORAL | TABLET, FILM COATED | NDA208065 | 5e81b4a7-b971-45e1-9c31-29cea8c87ce7 |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 5e81b4a7-b971-45e1-9c31-29cea8c87ce7 (view SPL) | These highlights do not include all the information needed to use TAGRISSO safely and effectively. See full prescribing information for TAGRISSO. TAGRISSO (osimertinib) tablet, for oral useInitial U.S. Approval: 2015 | prescription | Human Prescription | Astrazeneca Pharmaceuticals Lp | 2015-11-13 | 1 | 003101349, 003101350 |