Details for New Drug Application (NDA): 208194
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NDA 208194 describes BENDEKA, which is a drug marketed by Eagle Pharms and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BENDEKA profile page.
The generic ingredient in BENDEKA is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
The generic ingredient in BENDEKA is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
Summary for 208194
| Tradename: | BENDEKA |
| Applicant: | Eagle Pharms |
| Ingredient: | bendamustine hydrochloride |
| Patents: | 16 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208194
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 208194
Suppliers and Packaging for NDA: 208194
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENDEKA | bendamustine hydrochloride | SOLUTION;IV (INFUSION) | 208194 | NDA | Teva Pharmaceuticals USA, Inc. | 63459-348 | 63459-348-04 | 1 VIAL, MULTI-DOSE in 1 CARTON (63459-348-04) / 4 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;IV (INFUSION) | Strength | 100MG/4ML (25MG/ML) | ||||
| Approval Date: | Dec 7, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 7, 2022 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PATIENTS WITH CLL AND TREATMENT OF PATIENTS WITH INDOLENT B-CELL NHL THAT HAS PROGRESSED DURING OR WITHIN SIX MONTHS OF TREATMENT WITH RITUXIMAB OR A RITUXIMAB CONTAINING REGIMEN | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 28, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 15, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA | ||||||||
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