Eltrombopag - Generic Drug Details
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Generic filers with tentative approvals for ELTROMBOPAG
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 75MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 50MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 25MG | 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 eltrombopag
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-004 | Oct 20, 2011 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-003 | Sep 8, 2009 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | Nov 20, 2008 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-003 | Sep 8, 2009 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-005 | Nov 16, 2012 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |