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Last Updated: December 7, 2022

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 12.5MG;150MG TABLET;ORAL
Cipla Limited hydrochlorothiazide; irbesartan 201616 12.5MG; 300MG TABLET; ORAL
Macleods Pharms Ltd hydrochlorothiazide; irbesartan 202414 12.5MG;150MG TABLET;ORAL
Lupin Ltd hydrochlorothiazide; irbesartan 201524 12.5MG;300MG TABLET;ORAL
>Applicant >Generic Name >NDA >Strength >Dosage Form

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
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Boehringer Ingelheim

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