Osimertinib - Generic Drug Details
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Generic filers with tentative approvals for OSIMERTINIB
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 80MG | TABLET;ORAL |
| ⤷ Start Trial | ⤷ Start Trial | 40MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for Osimertinib
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | TAGRISSO | osimertinib mesylate | TABLET;ORAL | 208065-002 | Nov 13, 2015 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Astrazeneca | TAGRISSO | osimertinib mesylate | TABLET;ORAL | 208065-002 | Nov 13, 2015 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Astrazeneca | TAGRISSO | osimertinib mesylate | TABLET;ORAL | 208065-001 | Nov 13, 2015 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
