Alembic Pharmaceuticals gets USFDA approval for Dapsone Gel, 5%
Dapsone Gel is indicated for the topical treatment of acne vulgaris
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Browsing Tag
ANDA approval
Alembic gets USFDA nod for Oseltamivir Phosphate for Oral Suspension
Oseltamivir Phosphate is an influenza neuraminidase inhibitor (NAI) indicated for treatment of acute, uncomplicated…
Lupin gets tentative nod from US FDA for Enzalutamide tablets
The tentative approval covers the 40 mg, 80 mg, 120 mg, and 160 mg strengths
Alembic receives USFDA tentative approval for Larotrectinib Capsules ANDA
Company becomes sole first applicant for generic Larotrectinib Capsules with Paragraph IV certification
Lupin receives US FDA approval for generic colonoscopy preparation tablets
Approval grants Lupin 180-day generic drug exclusivity for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride Tablets in…
Lupin receives US FDA approval for Dapagliflozin tablets
Approval confirms bioequivalence to Farxiga for approved indications
Alembic Pharmaceuticals receives USFDA approval for Lamotrigine Orally Disintegrating tablets
Company secures final approval for ANDA across four strengths; cumulative USFDA ANDA approvals reach 235
Lupin receives US FDA approval for Brivaracetam Oral Solution 10 mg/mL
Company initiates US launch following ANDA approval for bioequivalent to Briviact
Granules Pharma receives USFDA tentative approval for amphetamine ER ODT ANDA
Approval covers multiple strengths for ADHD treatment, to be manufactured at US facility
Alembic Pharmaceuticals receives USFDA approval for Sumatriptan single-dose autoinjector
The product marks Alembic’s first drug–device combination to be approved in the United States