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Results For "ANDA-approvals"

145 News Found

Granules India FDA approval for ADHD treatment
Drug Approval | December 17, 2024

Granules India FDA approval for ADHD treatment


Alembic Pharmaceuticals gets USFDA tentative approval for OTC
Drug Approval | December 05, 2024

Alembic Pharmaceuticals gets USFDA tentative approval for OTC

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander


Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules
Drug Approval | November 11, 2024

Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules

Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension


Alembic Pharmaceuticals Q2 FY25 PAT up 12% to Rs. 153 Cr
News | November 07, 2024

Alembic Pharmaceuticals Q2 FY25 PAT up 12% to Rs. 153 Cr

US Generics grew 5% to Rs. 467 Crores for the quarter


Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules
Drug Approval | October 21, 2024

Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules

Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension


Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets
Drug Approval | October 19, 2024

Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets

Granules now has a total of 67 ANDA approvals from the USFDA


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


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