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Results For "US-Food-&-Drug-Administration"

7 News Found

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 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 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 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


Granules India receives ANDA approval for Levetiracetam Tablets
Drug Approval | June 15, 2023

Granules India receives ANDA approval for Levetiracetam Tablets

Granules now has a total of 58 ANDA approvals from US FDA


Alembic gets USFDA approval for Lurasidone Hydrochloride tablets
News | May 15, 2021

Alembic gets USFDA approval for Lurasidone Hydrochloride tablets

Lurasidone Hydrochloride tablets are also indicated for adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder


Granules India gets USFDA approval of acetaminophen, aspirin and caffeine tablets
News | February 25, 2021

Granules India gets USFDA approval of acetaminophen, aspirin and caffeine tablets

ranules now has a total of 38 ANDA approvals from US FDA.