Unichem Labs gets US FDA approval for Amitriptyline HCL Tablets
They are indicated for the relief of symptoms of depression
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Browsing Tag
USFDA
SK bioscience’s COVID-19 vaccine plant in South Korea gets European nod
The certification approves the production and processing line and quality system of SK bioscience's Andong plant, which produces…
Alembic Pharma gets USFDA Final nod for Lurasidone Hydrochloride Tablets
They are indicated for monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode…
Alembic Pharma gets USFDA final approval for Doxepin Hydrochloride Capsules
Doxepin Hydrochloride Capsules are recommended for the treatment of depression and anxiety
Zydus Cadila gets final US FDA approval for Propafenone Hydrochloride ER capsules
Propafenone is known as an anti-arrhythmic drug
Caplin Steriles gets USFDA approval for Neostigmine Methylsulfate Injection
It is indicated for the reversal of the effects of non-depolarising neuromuscular blocking agents after surgery
NATCO gets tentative US FDA approval for Ibrutinib tablets
NATCO feels that it is eligible for 180 days of sole generic marketing exclusivity for all the strengths of the tablet dosage form…
Aleor Dermaceuticals gets tentative USFDA approval for Efinaconazole Topical Solution
It is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton…
Zydus Cadila gets final USFDA nod for Macitentan Tablets and eligibility for 180-day shared…
Macitentan is used to manage the symptoms of pulmonary arterial hypertension
Aleor Dermaceuticals gets USFDA nod for Nystatin and Triamcinolone Acetonide Cream
It is indicated for the treatment of cutaneous candidiasis