Generic Companies with Tentative Approvals for: mirabegron
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mirabegron 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 Pharmaceutical Co., Ltd. | mirabegron | 217989 | 50MG | TABLET, EXTENDED RELEASE |
Qilu Pharmaceutical Co., Ltd. | mirabegron | 217989 | 25MG | TABLET, EXTENDED RELEASE |
Ascent Pharms Inc | mirabegron | 218172 | 25MG | TABLET, EXTENDED RELEASE |
Aurobindo Pharma Ltd | mirabegron | 209413 | 50MG | TABLET, EXTENDED RELEASE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |