Generic Companies with Tentative Approvals for: bendamustine
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bendamustine Generic Filers with Tentative Approvals
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Applicant | Generic Name | NDA | Strength | Dosage Form |
---|---|---|---|---|
Dr Reddys Labs Ltd | bendamustine hydrochloride | 215668 | 100MG/4ML (25MG/ML) | SOLUTION;INTRAVENOUS |
Eugia Pharma Speclts | bendamustine hydrochloride | 214739 | 100MG/VIAL | POWDER;IV (INFUSION) |
Mylan Labs Ltd | bendamustine hydrochloride | 204104 | 25MG/VIAL | POWDER;IV (INFUSION) |
Hospira Inc | bendamustine hydrochloride | 204086 | 25MG/VIAL | POWDER;IV (INFUSION) |
Celerity Pharms | bendamustine hydrochloride | 209814 | 25MG/VIAL | POWDER;IV (INFUSION) |
Mylan Labs Ltd | bendamustine hydrochloride | 204104 | 100MG/VIAL | POWDER;IV (INFUSION) |
Innopharma Licensing | bendamustine hydrochloride | 205476 | 25MG/VIAL | POWDER;IV (INFUSION) |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |