Details for New Drug Application (NDA): 205574
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NDA 205574 describes BENDAMUSTINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Meitheal, Nang Kuang Pharm Co, Norvium Bioscience, Baxter Hlthcare Corp, and Hospira, and is included in eleven 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 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 BENDAMUSTINE HYDROCHLORIDE 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 205574
| Tradename: | BENDAMUSTINE HYDROCHLORIDE |
| Applicant: | Accord Hlthcare |
| Ingredient: | bendamustine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 205574
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 205574
Suppliers and Packaging for NDA: 205574
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | POWDER;INTRAVENOUS | 205574 | ANDA | Accord Healthcare, Inc. | 16729-250 | 16729-250-03 | 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-250-03) / 5 mL in 1 VIAL, SINGLE-DOSE |
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | POWDER;INTRAVENOUS | 205574 | ANDA | Accord Healthcare, Inc. | 16729-251 | 16729-251-05 | 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-251-05) / 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: | Dec 7, 2022 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 100MG/VIAL | ||||
| Approval Date: | Dec 7, 2022 | TE: | AP | RLD: | No | ||||
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