Details for New Drug Application (NDA): 211530
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NDA 211530 describes BENDAMUSTINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Kindos, Mylan Labs Ltd, Nang Kuang Pharm Co, 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 are twenty-three drug master file entries for this compound. Ten 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 are twenty-three drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.
Summary for 211530
| Tradename: | BENDAMUSTINE HYDROCHLORIDE |
| Applicant: | Hospira |
| Ingredient: | bendamustine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 211530
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 25MG/ML (25MG/ML) | ||||
| Approval Date: | Dec 15, 2022 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/4ML (25MG/ML) | ||||
| Approval Date: | Dec 15, 2022 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MG/8ML (25MG/ML) | ||||
| Approval Date: | Dec 15, 2022 | TE: | RLD: | Yes | |||||
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