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Generic Companies with Tentative Approvals for: Zydus Pharms Usa Inc
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Zydus Pharms Usa Inc 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 |
---|---|---|---|---|
Zydus Pharms Usa Inc | febuxostat | 205443 | 40MG | TABLET;ORAL |
Zydus Pharms Usa Inc | irbesartan; hydrochlorothiazide | 090815 | 150MG; 12.5MG | TABLET; ORAL |
Zydus Pharms Usa Inc | letrozole | 090405 | 2.5MG | TABLET; ORAL |
Zydus Pharms Usa Inc | irbesartan; hydrochlorothiazide | 090815 | 300MG; 12.5MG | TABLET; ORAL |
Zydus Pharms Usa Inc | linagliptin | 208448 | 5MG | TABLET;ORAL |
Zydus Pharms Usa Inc | clofarabine | 208167 | 20MG/20ML | INJECTABLE;INJECTION |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |