Details for New Drug Application (NDA): 214739
NDA 214739 describes BENDAMUSTINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Meitheal, Nang Kuang Pharm Co, Pharmobedient, Baxter Hlthcare Corp, and Hospira, and is included in eleven NDAs. It is available from six suppliers. Additional details are available on the BENDAMUSTINE HYDROCHLORIDE profile page.
The generic ingredient in BENDAMUSTINE HYDROCHLORIDE 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 BENDAMUSTINE HYDROCHLORIDE 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 214739
| Tradename: | BENDAMUSTINE HYDROCHLORIDE |
| Applicant: | Eugia Pharma |
| Ingredient: | bendamustine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 214739
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 214739
Suppliers and Packaging for NDA: 214739
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | POWDER;INTRAVENOUS | 214739 | ANDA | Eugia US LLC | 55150-391 | 55150-391-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-391-01) / 5 mL in 1 VIAL, SINGLE-DOSE |
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | POWDER;INTRAVENOUS | 214739 | ANDA | Eugia US LLC | 55150-392 | 55150-392-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-392-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 25MG/VIAL | ||||
| Approval Date: | Jun 5, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 100MG/VIAL | ||||
| Approval Date: | Jun 5, 2023 | TE: | AP | RLD: | No | ||||
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