Rilpivirine - Generic Drug Details
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Generic filers with tentative approvals for RILPIVIRINE
Applicant | Application No. | Strength | Dosage Form |
⤷ 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 rilpivirine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Prods | EDURANT PED | rilpivirine hydrochloride | TABLET, FOR SUSPENSION;ORAL | 219016-001 | Mar 15, 2024 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Janssen Prods | EDURANT | rilpivirine hydrochloride | TABLET;ORAL | 202022-001 | May 20, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Janssen Prods | EDURANT PED | rilpivirine hydrochloride | TABLET, FOR SUSPENSION;ORAL | 219016-001 | Mar 15, 2024 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |