Bendamustine - Generic Drug Details
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Generic filers with tentative approvals for BENDAMUSTINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 100MG/VIAL | POWDER;IV (INFUSION) |
⤷ Try a Trial | ⤷ Try a Trial | 25MG/VIAL | POWDER;IV (INFUSION) |
⤷ Try a Trial | ⤷ Try a Trial | 100MG/VIAL | POWDER;IV (INFUSION) |
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 bendamustine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex | BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | SOLUTION;INTRAVENOUS | 215033-001 | Dec 7, 2022 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Cephalon | TREANDA | bendamustine hydrochloride | POWDER;IV (INFUSION) | 022249-001 | Mar 20, 2008 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Baxter Hlthcare Corp | BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | SOLUTION;INTRAVENOUS | 216078-001 | Dec 15, 2022 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Eagle Pharms | BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194-001 | Dec 7, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |