Generic Companies with Tentative Approvals for: Breckenridge
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Breckenridge 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 |
---|---|---|---|---|
Breckenridge | carfilzomib | 209330 | 60MG/VIAL | POWDER;INTRAVENOUS |
Breckenridge Pharms | dabigatran etexilate mesylate | 207922 | 110MG | CAPSULE;ORAL |
Breckenridge | carfilzomib | 209330 | 10MG/VIAL | POWDER;INTRAVENOUS |
Breckenridge Pharms | dabigatran etexilate mesylate | 207922 | 150MG | CAPSULE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |