Generic Companies with Tentative Approvals for: Novel Labs Inc
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Novel Labs 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 |
---|---|---|---|---|
Novel Labs Inc | azithromycin | 202793 | EQ 100MG BASE/5ML | FOR SUSPENSION;ORAL |
Novel Labs Inc | pregabalin | 202269 | 20MG/ML | SOLUTION;ORAL |
Novel Labs Inc | azithromycin | 202793 | EQ 200MG BASE/5ML | FOR SUSPENSION;ORAL |
Novel Labs Inc | polyethylene glycol 3350; sodium chloride; sodium bicarbonate; potassium chloride; bisacodyl | 090197 | 2MG; 5MG | SOLUTION; ORAL AND TABLET; DELAYED RELEASE |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |