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News about "Reference Listed Drug (RLD) "
Glenmark Specialty SA Receives US FDA Approval for Fluticasone Propionate Inhalation Aerosol USP
Glenmark Pharmaceuticals’s subsidiary Glenmark Specialty SA has received approval from the US Food and Drug Administration (FDA) for Fluticasone Propionate Inhalation Aerosol USP, 44 mcg per actuation, along with 180-day Competitive Generic Therapy exclusivity. The product has been deemed bioequivalent and therapeutically equivalent to Flovent HFA.
Reference Listed Drug (RLD) | 05/03/2026 | By Akanki | 101
Zydus Gets USFDA Tentative Nod for Dapagliflozin Tablets
Zydus has received tentative approval from the US Food and Drug Administration (USFDA) for dapagliflozin tablets in 5 mg and 10 mg strengths, paving the way for the company’s entry into the US market subject to final approval.
Reference Listed Drug (RLD) | 06/02/2026 | By News Bureau | 119
Alembic Pharma Secures US FDA Tentative Approval for Bosutinib Tablets
The USFDA’s tentative approval confirms that Alembic Pharmaceuticals’ Bosutinib Tablets, 400 mg, meet therapeutic equivalence requirements with the Reference Listed Drug (RLD) Bosulif, marking an important step towards potential market entry.
Reference Listed Drug (RLD) | 12/01/2026 | By News Bureau | 166
Glenmark Launches Epinephrine Injection Multi-Dose Vial
Glenmark has introduced its Epinephrine Injection USP, 1?mg/mL, 30?mg/30?mL multiple-dose vial, which is bioequivalent and therapeutically equivalent to the reference drug by BPI Labs, LLC (NDA 205029), offering a reliable alternative for patients and healthcare providers.
Reference Listed Drug (RLD) | 23/12/2025 | By News Bureau | 141
Alembic Pharma Wins USFDA Approval for Travoprost Ophthalmic Solution
Alembic Pharmaceuticals has secured USFDA approval for its Travoprost Ophthalmic Solution, with the ANDA deemed therapeutically equivalent to the reference listed drug Travatan Z (0.004%) from Sandoz.
Reference Listed Drug (RLD) | 18/12/2025 | By News Bureau | 102
Alembic Pharmaceuticals Gets USFDA Nod for Triamcinolone Acetonide Injection
The approved ANDA, Triamcinolone Acetonide Injection, is therapeutically equivalent to the Reference Listed Drug (RLD) product, Kenalog-40 Injectable Suspension, of Bristol-Myers Squibb company.
Reference Listed Drug (RLD) | 21/10/2025 | By Dineshwori | 275
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