Generic Companies with Tentative Approvals for: irbesartan; hydrochlorothiazide
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irbesartan; hydrochlorothiazide 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 | irbesartan; hydrochlorothiazide | 090815 | 150MG; 12.5MG | TABLET; ORAL |
Zydus Pharms Usa Inc | irbesartan; hydrochlorothiazide | 090815 | 300MG; 12.5MG | TABLET; ORAL |
Lupin Ltd | irbesartan; hydrochlorothiazide | 201524 | 300MG; 25MG | TABLET; ORAL |
Zydus Pharms Usa Inc | irbesartan; hydrochlorothiazide | 090815 | 300MG; 25MG | TABLET; ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |