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Results For "ANDA-approvals"

138 News Found

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


Granules India received ANDA approval for Metoprolol Succinate ER Tablets
Drug Approval | June 14, 2023

Granules India received ANDA approval for Metoprolol Succinate ER Tablets

Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.


Granules India received ANDA approval for Venlafaxine ER capsules
Drug Approval | May 20, 2023

Granules India received ANDA approval for Venlafaxine ER capsules

Venlafaxine HCl extended-release capsules are indicated for the treatment of: Major Depressive Disorder


Alembic receives USFDA final approval for Brimonidine Tartrate Ophthalmic Solution
Drug Approval | March 31, 2023

Alembic receives USFDA final approval for Brimonidine Tartrate Ophthalmic Solution

Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure


Granules India receives ANDA approval for Gabapentin Tablets
Drug Approval | March 30, 2023

Granules India receives ANDA approval for Gabapentin Tablets

Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults


Alembic receives USFDA final approval for Prazosin Hydrochloride Capsules
Drug Approval | March 09, 2023

Alembic receives USFDA final approval for Prazosin Hydrochloride Capsules

Prazosin Hydrochloride Capsule is indicated for the treatment of hypertension, to lower blood pressure


Caplin Steriles gets USFDA approval for Thiamine Hydrochloride Injection
Drug Approval | March 09, 2023

Caplin Steriles gets USFDA approval for Thiamine Hydrochloride Injection

Thiamine Hydrochloride Injection is effective in the treatment of vitamin B1 deficiency (beriberi)


Alembic Pharmaceuticals gets USFDA final approval for fluorouracil injection
Drug Approval | March 07, 2023

Alembic Pharmaceuticals gets USFDA final approval for fluorouracil injection

Fluorouracil Injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum and breast