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Results For "Alembic"

113 News Found

Alembic receives USFDA final approval for Dabigatran Etexilate Capsules, 110 mg
Drug Approval | August 13, 2024

Alembic receives USFDA final approval for Dabigatran Etexilate Capsules, 110 mg

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals


Alembic receives USFDA final approval for Nelarabine Injection, 250 mg/50 mL
Drug Approval | August 03, 2024

Alembic receives USFDA final approval for Nelarabine Injection, 250 mg/50 mL

Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia


Briefs: Indoco Remedies and Alembic Pharmaceuticals
Drug Approval | July 29, 2024

Briefs: Indoco Remedies and Alembic Pharmaceuticals

Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe


Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial
Drug Approval | July 14, 2024

Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial

Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension


Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%
Drug Approval | July 10, 2024

Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%

The approved ANDA is therapeutically equivalent to the reference listed drug product


Briefs: Alembic Pharmaceuticals  and Relonchem
Drug Approval | July 05, 2024

Briefs: Alembic Pharmaceuticals and Relonchem

Alembic Pharmaceuticals receives 11 USFDA product approval during Q1 FY2025