Details for New Drug Application (NDA): 215033
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NDA 215033 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 215033
| Tradename: | BENDAMUSTINE HYDROCHLORIDE |
| Applicant: | Apotex |
| Ingredient: | bendamustine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215033
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 215033
Suppliers and Packaging for NDA: 215033
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | SOLUTION;INTRAVENOUS | 215033 | NDA | Apotex Corp | 60505-6228 | 60505-6228-0 | 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6228-0) / 5 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: | Dec 7, 2022 | TE: | AP | RLD: | Yes | ||||
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