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Results For "reference-listed-drug"

180 News Found

Alembic receives USFDA final approval for Alcaftadine Ophthalmic Solution, 0.25% (OTC)
Drug Approval | October 04, 2024

Alembic receives USFDA final approval for Alcaftadine Ophthalmic Solution, 0.25% (OTC)

Alcaftadine Ophthalmic Solution, 0.25% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander


Indoco Remedies receives final ANDA approval from the USFDA for Cetirizine Hydrochloride Tablets
Drug Approval | October 04, 2024

Indoco Remedies receives final ANDA approval from the USFDA for Cetirizine Hydrochloride Tablets

Cetirizine is used for relief of symptoms of hay fever and other allergic conditions


Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets
Drug Approval | October 03, 2024

Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets

Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures


Aurobindo Pharma receives USFDA approval for Cephalexin Tablets
Drug Approval | October 02, 2024

Aurobindo Pharma receives USFDA approval for Cephalexin Tablets

The product is expected to be launched in Q3FY25


Alembic receives USFDA final approval for Paliperidone ER tablets
News | September 27, 2024

Alembic receives USFDA final approval for Paliperidone ER tablets

Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia


Strides receives USFDA approval for Fluoxetine Tabs 60 mg
Drug Approval | September 16, 2024

Strides receives USFDA approval for Fluoxetine Tabs 60 mg

Fluoxetine Tabs 60 mg approval solidifies the company's position in the molecule by complementing the recent approval in April 2024 for Fluoxetine 10 mg and 20 mg tablets and Fluoxetine capsules


Strides receive USFDA approval for Theophylline ER tablets, 300 mg and 450 mg
Drug Approval | September 06, 2024

Strides receive USFDA approval for Theophylline ER tablets, 300 mg and 450 mg

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug


Granules India receives ANDA approval for Glycopyrrolate Oral Solution
Drug Approval | August 20, 2024

Granules India receives ANDA approval for Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients