FDA
Bendamustine Hydrochloride
The FDA lists this product in 28 strengths and forms.
Composition
- Active ingredients
- BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML)
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) · SolutionNDA219014-001 · Prescription
- BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL · PowderANDA204771-002 · Tentative approval
- BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL · PowderANDA204771-001 · Tentative approval
- BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL · PowderANDA205376-002 · Prescription
- BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL · PowderANDA205376-001 · Prescription
- BENDAMUSTINE HYDROCHLORIDE 100MG/4ML (25MG/ML) · SolutionNDA215033-001 · Prescription
- BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL · PowderANDA205574-002 · Prescription
- BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL · PowderANDA205574-001 · Prescription
- BENDAMUSTINE HYDROCHLORIDE 25MG/VIAL · PowderANDA205447-001 · Discontinued
- BENDAMUSTINE HYDROCHLORIDE 100MG/VIAL · PowderANDA205447-002 · Discontinued
At a glance
- Brand name
- Bendamustine Hydrochloride
- Route
- Iv (infusion)
- Dosage form
- Solution
- Applicant
- Fresenius Kabi USA
- Status
- Tentative approval
- FDA approval
- 13 Nov 2018
- Application
- ANDA210410-001