Generic Companies with Tentative Approvals for: Apotex Inc
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Apotex 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 |
|---|---|---|---|---|
| Apotex Inc | levocetirizine dihydrochloride | 211528 | 2.5MG/5ML | SOLUTION;ORAL |
| Apotex Inc | vortioxetine hydrobromide | 211130 | 10MG | TABLET |
| Apotex Inc | eletriptan hydrobromide | 201536 | 40MG | TABLET; ORAL |
| Apotex Inc | zoledronic acid | 078533 | EQ 4MG BASE/5ML | INJECTABLE; IV (INFUSION) |
| >Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |
