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 twenty 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 is one drug master file entry for this compound. Twelve 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 is one drug master file entry for this compound. Twelve 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: | 20 |
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;INTRAVENOUS | 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;INTRAVENOUS | Strength | 100MG/4ML (25MG/ML) | ||||
| Approval Date: | Dec 7, 2015 | TE: | RLD: | Yes | |||||
| Patent: | 10,010,533 | Patent Expiration: | Jan 28, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,052,385 | Patent Expiration: | Mar 15, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA | ||||||||
| Patent: | 10,052,385 | Patent Expiration: | Mar 15, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA | ||||||||
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