Details for New Drug Application (NDA): 205580
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NDA 205580 describes BELRAPZO, which is a drug marketed by Eagle Pharms and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the BELRAPZO profile page.
The generic ingredient in BELRAPZO is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
The generic ingredient in BELRAPZO is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
Summary for 205580
| Tradename: | BELRAPZO |
| Applicant: | Eagle Pharms |
| Ingredient: | bendamustine hydrochloride |
| Patents: | 11 |
Pharmacology for NDA: 205580
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 205580
Suppliers and Packaging for NDA: 205580
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BELRAPZO | bendamustine hydrochloride | SOLUTION;INTRAVENOUS | 205580 | NDA | Eagle Pharmaceuticals, Inc | 42367-521 | 42367-521-25 | 1 VIAL, MULTI-DOSE in 1 CARTON (42367-521-25) / 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: | May 15, 2018 | TE: | AP | RLD: | Yes | ||||
| Patent: | 10,010,533 | Patent Expiration: | Jan 28, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,103,483 | Patent Expiration: | Jan 28, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA | ||||||||
| Patent: | 11,103,483 | Patent Expiration: | Jan 28, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA | ||||||||
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