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Results For "Abbreviated-New-Drug-Application"

294 News Found

Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets
Drug Approval | May 30, 2024

Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death


Cipla receives final approval for the generic version of Somatuline Depot Injection
Drug Approval | May 23, 2024

Cipla receives final approval for the generic version of Somatuline Depot Injection

Cipla's Lanreotide Injection is AP-rated therapeutic equivalent generic version of Somatuline Depot (Lanreotide) Injection


Lupin receives USFDA approval for travoprost ophthalmic solution
Drug Approval | May 07, 2024

Lupin receives USFDA approval for travoprost ophthalmic solution

Travoprost Ophthalmic Solution USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.


Granules India announced ANDA Approval for Colchicine Capsules
Drug Approval | May 01, 2024

Granules India announced ANDA Approval for Colchicine Capsules

Colchicine Capsules are indicated for prophylaxis of gout flares in adult


Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution
Drug Approval | April 17, 2024

Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution

Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers


Lupin receives approval from USFDA for Minzoya
Drug Approval | February 17, 2024

Lupin receives approval from USFDA for Minzoya

Minzoya Tablets are indicated for use by females of reproductive potential to prevent pregnancy


Lupin receives USFDA’s approval for Febuxostat Tablets
Drug Approval | January 19, 2024

Lupin receives USFDA’s approval for Febuxostat Tablets

Febuxostat Tablets (RLD Uloric) had estimated annual sales of US$ 27 million in the U.S. (IQVIA MAT November 2023)