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Results For "reference-listed-drug-product"

81 News Found

Alembic Pharmaceuticals announces USFDA final approval for Amlodipine and Atorvastatin Tablets USP
Drug Approval | May 24, 2025

Alembic Pharmaceuticals announces USFDA final approval for Amlodipine and Atorvastatin Tablets USP

Amlodipine and Atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin


Alembic receives USFDA final approval for Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg
Drug Approval | May 03, 2025

Alembic receives USFDA final approval for Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg

Ticagrelor tablets are indicated for to reduce the risk of cardiovascular death and myocardial infarction,


Alembic announces USFDA Final Approval for Carbamazepine Tablets USP, 200 mg
Drug Approval | April 17, 2025

Alembic announces USFDA Final Approval for Carbamazepine Tablets USP, 200 mg

Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve months ending December 2024 according to IQVIA


Alembic announces USFDA final approval for Pantoprazole Sodium for Injection, 40 mg/vial
Drug Approval | April 03, 2025

Alembic announces USFDA final approval for Pantoprazole Sodium for Injection, 40 mg/vial

Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial) have an estimated market size of US$ 48 million for twelve months ending December 2024 according to IQVIA


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


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 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