Generic Companies with Tentative Approvals for: Novast Labs
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Novast 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 |
---|---|---|---|---|
Novast Labs Ltd | metformin hydrochloride, sitagliptin | 218069 | 50MG | TABLET, EXTENDED RELEASE |
Novast Labs Ltd | memantine hydrochloride | 214731 | 7MG | CAPSULE, EXTENDED RELEASE;ORAL |
Novast Labs Ltd | ethinyl estradiol; norethindrone acetate | 208661 | 0.01MG,0.01MG;1MG,N/A | TABLET;ORAL |
Novast Labs Ltd | oxcarbazepine | 218724 | 600MG | TABLET, EXTENDED RELEASE |
Novast Labs Ltd | metformin hydrochloride, sitagliptin | 218069 | EQ 100MG BASE TABLET | TABLET, EXTENDED RELEASE |
Novast Labs Ltd | metformin hydrochloride, sitagliptin | 218069 | 500MG | TABLET, EXTENDED RELEASE |
Novast Labs Ltd | memantine hydrochloride | 214731 | 21MG | CAPSULE, EXTENDED RELEASE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |