Generic Companies with Tentative Approvals for: Glenmark Pharms Ltd
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Glenmark Pharms Ltd 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 |
---|---|---|---|---|
Glenmark Pharms Ltd | dabigatran etexilate mesylate | 207984 | EQ 110MG BASE | CAPSULE;ORAL |
Glenmark Pharms Ltd | gabapentin encarbil | 213501 | 300MG | TABLET, EXTENDED RELEASE;ORAL |
Glenmark Pharms Ltd | saxagliptin hydrochloride | 205994 | EQ 2.5MG BASE | TABLET;ORAL |
Glenmark Pharms Ltd | lacosamide | 204980 | 10MG/ML | SOLUTION;ORAL |
Glenmark Pharms Ltd | milnacipran hydrochloride | 205267 | 50MG | TABLET;ORAL |
Glenmark Pharms Ltd | saxagliptin hydrochloride | 205994 | EQ 5MG BASE | TABLET;ORAL |
Glenmark Pharms Ltd | bendamustine hydrochloride | 204771 | 25MG/VIAL | POWDER;IV (INFUSION) |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |