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Results For "reference-listed-drug"

186 News Found

Lupin launches Thiamine Hydrochloride Injection USP in the US
Drug Approval | June 19, 2023

Lupin launches Thiamine Hydrochloride Injection USP in the US

Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.


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.


Eugia Pharma receives USFDA approval for Carboprost Tromethamine Injection
Drug Approval | May 27, 2023

Eugia Pharma receives USFDA approval for Carboprost Tromethamine Injection

The product is expected to be launched in June 2023


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


Shilpa Medicare receives USFDA approval for Psoriatic Arthritis Drug
Drug Approval | April 11, 2023

Shilpa Medicare receives USFDA approval for Psoriatic Arthritis Drug

Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.


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


Marksans Pharma announces USFDA approval for Famotidine Tablets
News | March 11, 2023

Marksans Pharma announces USFDA approval for Famotidine Tablets

Marksans' OTC Famotidine Tablets USP are acid reducers