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Results For "reference-listed-drug"

223 News Found

Caplin Steriles gets FDA approval for desmopressin
Drug Approval | March 02, 2026

Caplin Steriles gets FDA approval for desmopressin

Desmopressin Acetate Injection is primarily used to treat central diabetes insipidus, haemophilia A, and von Willebrand disease


Alembic Pharma secures USFDA approval for generic Lamotrigine orally disintegrating tablets
Drug Approval | February 26, 2026

Alembic Pharma secures USFDA approval for generic Lamotrigine orally disintegrating tablets

The approved product is a generic version of the reference listed drug (RLD) Lamictal ODT by GlaxoSmithKline and is indicated for the treatment of epilepsy and bipolar disorder


Alembic announces USFDA final approval for Efinaconazole Topical Solution, 10%
Drug Approval | February 25, 2026

Alembic announces USFDA final approval for Efinaconazole Topical Solution, 10%

Efinaconazole Topical Solution is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.


Caplin Steriles gets USFDA approval for Sodium Phosphate injection
Drug Approval | February 25, 2026

Caplin Steriles gets USFDA approval for Sodium Phosphate injection

Sodium Phosphates Injection is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake


Indoco Remedies receives final ANDA approval from USFDA for Brivaracetam Oral Solution, 10 mg/mL
Drug Approval | February 25, 2026

Indoco Remedies receives final ANDA approval from USFDA for Brivaracetam Oral Solution, 10 mg/mL

Brivaracetam Oral Solution (10 mg/mL) is a prescription antiepileptic drug (anticonvulsant) used for treatment of partial-onset seizures in patients 1 month of age and older


Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets
Drug Approval | February 07, 2026

Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets


Lupin launches Topiramate ER capsules in US
News | February 05, 2026

Lupin launches Topiramate ER capsules in US

Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals