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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 Pharm | bendamustine hydrochloride | 205447 | 25MG/VIAL | POWDER;IV (INFUSION) |
Breckenridge | asenapine maleate | 205960 | EQ 2.5MG BASE | TABLET;SUBLINGUAL |
Breckenridge Pharms | sodium sulfate;potassium sulfate;magnesium sulfate | 204135 | 17.5G;3.13G;1.6G | SOLUTION;ORAL |
Breckenridge Pharm | apixaban | 209845 | 2.5MG | TABLET;ORAL |
Breckenridge Pharm | apixaban | 209845 | 5MG | TABLET;ORAL |
Breckenridge Pharm | bendamustine hydrochloride | 205447 | 100MG/VIAL | POWDER;IV (INFUSION) |
Breckenridge | asenapine maleate | 205960 | EQ 10MG BASE | TABLET;SUBLINGUAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |