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Generic Companies with Tentative Approvals for: bortezomib
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bortezomib 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 |
---|---|---|---|---|
Qilu Pharm Co Ltd | bortezomib | 210824 | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
Pharmascience Inc | bortezomib | 208392 | 3.5MG/VIAL | INJECTABLE;INJECTION |
Actavis Llc | bortezomib | 208645 | 2.5MG/ML | INJECTABLE; INJECTION |
Apotex Inc | bortezomib | 205533 | 3.5MG/VIAL | VIAL |
Actavis Llc | bortezomib | 208645 | 3.5MG/1.4ML | INJECTABLE; INJECTION |
Accord Hlthcare Inc | bortezomib | 204405 | 3.5MG/VIAL | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |