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Alembic Pharmaceuticals receives USFDA approval for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension
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Alembic Pharmaceuticals receives USFDA approval for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension
Alembic Pharmaceuticals (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, 0.5 per cent / 0.3 per cent, in 5 mL and 10 mL presentations. The approved ANDA is listed as therapeutically equivalent to the reference listed drug (RLD) Zylet Ophthalmic Suspension, 0.5 per cent / 0.3 per cen…
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