Generic Companies with Tentative Approvals for: Hetero Labs
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Hetero Labs 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 |
---|---|---|---|---|
Hetero Labs Unit Iii | dapagliflozin | 211439 | 10MG | TABLET;ORAL |
Hetero Labs Unit Iii | lamivudine; nevirapine; zidovudine | 202157 | 150MG; 200MG; 300MG | TABLET; ORAL |
Hetero Labs Ltd V | eltrombopag | 206788 | 75MG | TABLET;ORAL |
Hetero Labs Ltd Iii | raltegravir | 203540 | 400MG | TABLET;ORAL |
Hetero Labs Ltd V | fingolimod hydrochloride | 207933 | EQ 0.5MG BASE | CAPSULE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |