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Results For "ANDA-approval"

201 News Found

Alembic announces USFDA final approval for Brexpiprazole Tablets
Drug Approval | January 16, 2025

Alembic announces USFDA final approval for Brexpiprazole Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets


Alembic Pharmaceuticals receives USFDA final approval for Divalproex Sodium Delayed-Release Capsules
Drug Approval | December 22, 2024

Alembic Pharmaceuticals receives USFDA final approval for Divalproex Sodium Delayed-Release Capsules

Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of US$ 61.1 million for twelve months ending September 2024 according to IQVIA


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

Granules India FDA approval for ADHD treatment


Eugia Pharma receives USFDA approval for Pazopanib Tablets, 200 mg
News | December 06, 2024

Eugia Pharma receives USFDA approval for Pazopanib Tablets, 200 mg

The approved product has an estimated market size of US$ 106 million for the twelve months ending October 2024, according to IQVIA


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


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