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Generic Companies with Tentative Approvals for: hydrochlorothiazide; irbesartan
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hydrochlorothiazide; irbesartan 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 |
---|---|---|---|---|
Prinston Inc | hydrochlorothiazide; irbesartan | 203072 | 25MG/300MG | TABLET;ORAL |
Watson Labs Inc | hydrochlorothiazide; irbesartan | 091539 | 12.5MG;150MG | TABLET;ORAL |
Apotex Inc | hydrochlorothiazide; irbesartan | 201505 | 12.5MG;300MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |