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Generic Companies with Tentative Approvals
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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 |
---|---|---|---|---|
Amneal Pharms | saxagliptin;metformin hydrochloride | 205942 | 5MG;1000MG | TABLET, EXTENDED RELEASE;ORAL |
Emcure Pharma | nevirapine | 078887 | 200MG | TABLET; ORAL |
Sandoz Inc | sitagliptin; metformin hydrochloride | 202388 | 50MG; 500MG | TABLET; ORAL |
Accord Hlthcare Inc | perampanel | 209877 | 6MG | TABLET;ORAL |
Anchen Pharms | metformin hydrochloride; sitagliptin phosphate | 204144 | 1GM; EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL |
Ranbaxy | fexofenadine hydrochloride | 076970 | 60MG | TABLET; ORAL |
Novast Labs Ltd | norgestimate; ethinyl estradiol | 090541 | 0.18MG; 0.025MG | TABLET; ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |