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Results For "Abbreviated-New-Drug-Application"

249 News Found

Lupin receives approval from FDA for Cyanocobalamin Nasal Spray
Drug Approval | July 04, 2023

Lupin receives approval from FDA for Cyanocobalamin Nasal Spray

Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)


Lupin receives USFDA approval for Tiotropium Dry Powder Inhaler
Drug Approval | June 22, 2023

Lupin receives USFDA approval for Tiotropium Dry Powder Inhaler

This product will be manufactured at Lupin's Pithampur facility in India


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.


Lupin receives USFDA approval from Obeticholic Acid Tablets
Drug Approval | June 01, 2023

Lupin receives USFDA approval from Obeticholic Acid Tablets

Obeticholic Acid Tablets had estimated annual sales of US$ 262 million in the U.S. (IQVIA MAT Mar 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


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


Lupin receives tentative approval from USFDA for Valbenazine capsules
Drug Approval | March 28, 2023

Lupin receives tentative approval from USFDA for Valbenazine capsules

Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).


Lupin receives tentative approval from USFDA for Obeticholic Acid Tablets
Drug Approval | March 24, 2023

Lupin receives tentative approval from USFDA for Obeticholic Acid Tablets

Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of US $255 million in the US (IQVIA MAT December 2022).