Details for New Drug Application (NDA): 211001
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NDA 211001 describes BENDAMUSTINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Meitheal, Nang Kuang Pharm Co, Pharmobedient, Avyxa Holdings, Baxter Hlthcare Corp, and Hospira, and is included in twelve NDAs. It is available from seven 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 211001
| Tradename: | BENDAMUSTINE HYDROCHLORIDE |
| Applicant: | Meitheal |
| Ingredient: | bendamustine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 211001
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 211001
Suppliers and Packaging for NDA: 211001
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | POWDER;INTRAVENOUS | 211001 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-102 | 71288-102-10 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-102-10) / 5 mL in 1 VIAL, SINGLE-DOSE |
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | POWDER;INTRAVENOUS | 211001 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-103 | 71288-103-20 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-103-20) / 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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