Indoco Remedies receives U.S. FDA approval for generic Cetirizine tablets
Indoco Remedies secures final approval from the U.S. FDA for its generic version of Zyrtec Allergy Tablets
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Browsing Tag
ANDA
Alembic gains USFDA final approval for Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and…
The approved ANDA is therapeutically equivalent to the reference listed drug product, Lamictal XR Extended-Release Tablets, 200…
Lupin gets US FDA nod for Bumetanide Injection, USP
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of $ 20 million in the US (IQVIA MAT July 2024)
Alembic gains final USFDA approval for Albendazole Tablets USP, 200 mg
Albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms…
Zydus gains final USFDA approval for Valbenazine Capsules
Valbenazine Capsules had annual sales of $ 1,993.6 million in the United States (IQVIA MAT June 2024)
Glenmark Pharmaceuticals receives ANDA approval for Topiramate Capsules USP, 15 mg and 25 mg
The drug as been determined by the FDA to be bioequivalent and therapeutically equivalent to Topamax Capsules
Lupin gains tentative FDA approval for Empagliflozin, Linagliptin, Metformin Hydrochloride ER…
This product will be manufactured at Lupin’s Pithampur facility in India
Alembic gets US FDA nod for Bromfenac Ophthalmic Solution, 0.07 per cent
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Prolensa Ophthalmic Solution, 0.07 per…
Alembic Pharma announces USFDA final approval for Icatibant injection, 30 mg/3 mL (10 mg/mL)…
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Firazyr Injection, 30 mg/3 mL (10…
Alembic announces USFDA approval for Sacubitril and Valsartan tablets
Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death and hospitalisation for heart failure in…