Details for New Drug Application (NDA): 022249
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NDA 022249 describes TREANDA, which is a drug marketed by Cephalon and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug and two Paragraph IV challenges. Additional details are available on the TREANDA profile page.
The generic ingredient in TREANDA 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 TREANDA 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 022249
| Tradename: | TREANDA |
| Applicant: | Cephalon |
| Ingredient: | bendamustine hydrochloride |
| Patents: | 9 |
Pharmacology for NDA: 022249
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 022249
Suppliers and Packaging for NDA: 022249
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TREANDA | bendamustine hydrochloride | POWDER;INTRAVENOUS | 022249 | NDA | Cephalon, LLC | 63459-390 | 63459-390-08 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63459-390-08) / 5 mL in 1 VIAL, SINGLE-DOSE |
| TREANDA | bendamustine hydrochloride | SOLUTION;INTRAVENOUS | 022249 | NDA | Cephalon, LLC | 63459-390 | 63459-390-08 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63459-390-08) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 100MG/VIAL | ||||
| Approval Date: | Mar 20, 2008 | TE: | AP | RLD: | Yes | ||||
| Patent: | 8,436,190*PED | Patent Expiration: | Apr 26, 2031 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 8,445,524*PED | Patent Expiration: | Sep 26, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 8,609,863*PED | Patent Expiration: | Jul 12, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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