Generic Companies with Tentative Approvals for: Mylan Pharma
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Mylan Pharma 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 Pharma | abacavir sulfate; lamivudine; zidovudine | 090309 | EQ 300MG BASE; 150MG; 300MG | TABLET; ORAL |
Mylan Pharma | levofloxacin | 090063 | 500MG | TABLET; ORAL |
Mylan Pharma | levofloxacin | 090063 | 750MG | TABLET; ORAL |
Mylan Pharma | rosiglitazone maleate | 078825 | 4MG | TABLET; ORAL |
Mylan Pharma | lopinavir; ritonavir | 091202 | 200MG; 50MG | TABLET; ORAL |
Mylan Pharma | levofloxacin | 090063 | 250MG | TABLET; ORAL |
Mylan Pharma | lopinavir; ritonavir | 091202 | 100MG; 25MG | TABLET; ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |