News about "reference listed drug "

Alembic Pharmaceuticals Gains USFDA Approval for Dapagliflozin Tablets ANDA

Alembic Pharmaceuticals Gains USFDA Approval for Dapagliflozin Tablets ANDA

Alembic Pharmaceuticals receives USFDA approval for Dapagliflozin Tablets ANDA, gaining eligibility for 180-day shared generic drug exclusivity and strengthening its diabetes portfolio.

Reference Listed Drug | 07/04/2026 | By News Bureau

Alembic Pharmaceuticals Secures US FDA Approval for Paroxetine ER Tablets

Alembic Pharmaceuticals Secures US FDA Approval for Paroxetine ER Tablets

U.S. Food and Drug Administration grants final approval to Alembic’s sANDA for paroxetine extended-release tablets, used in treating depression and anxiety-related disorders.

Reference Listed Drug | 30/03/2026 | By News Bureau

ANI Pharmaceuticals Introduces Prucalopride Tablets after FDA Approval

ANI Pharmaceuticals Introduces Prucalopride Tablets after FDA Approval

ANI’s Prucalopride Tablets is the generic version of the reference listed drug (RLD) Motegrity.

Reference Listed Drug | 03/01/2025 | By Aishwarya 578


 

 

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