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Generic Companies with Tentative Approvals for: Mylan
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Mylan 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 |
---|---|---|---|---|
Mylan Labs Ltd | methylnaltrexone bromide | 208592 | 12MG/0.6ML | INJECTABLE;SUBCUTANEOUS |
Mylan | quinapril hydrochloride | 076036 | EQ 20MG BASE | TABLET;ORAL |
Mylan Pharms Inc | darunavir | 202136 | 600MG | TABLET; ORAL |
Mylan Pharma | levofloxacin | 090063 | 750MG | TABLET; ORAL |
Mylan Pharms Inc | zolpidem tartrate | 078016 | 5MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |