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Results For "Abbreviated-New-Drug-Application"

249 News Found

Lupin receives approval from USFDA for Brexpiprazole Tablets
Drug Approval | March 22, 2023

Lupin receives approval from USFDA for Brexpiprazole Tablets

Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)


Caplin receives USFDA approval for Rocuronium Bromide Injection
Drug Approval | March 21, 2023

Caplin receives USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)


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


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


Caplin Steriles gets USFDA approval for Rocuronium Bromide Injection
Drug Approval | March 04, 2023

Caplin Steriles gets USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection is a neuromuscular blocking agent


Granules India gets USFDA approval for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg
Drug Approval | February 27, 2023

Granules India gets USFDA approval for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg

Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.