Alembic Pharma gets USFDA approval for Brimonidine Tartrate Ophthalmic Solution, 0.15%
Brimonidine Tartrate Ophthalmic Solution is an alpha-adrenergic receptor agonist indicated for the reduction of elevated…
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Alembic Pharmaceuticals
Alembic Pharma gets USFDA nod for Fluorouracil Injection USP, 2.5 g/50 mL pharmacy bulk vial
It is indicated for the treatment of patients with adenocarcinoma of colon and rectum, adenocarcinoma of the breast, gastric…
Alembic Pharma gets USFDA nod for Docetaxel Injection USP
Docetaxcel Injections are indicated for breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric…
NATCO announces ANDA filing for generic olaparib tablets in US
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic and prostrate cancer
Aleor Dermaceuticals gets USFDA approval for Diclofenac Sodium Topical Gel
It is indicated for the topical treatment of actinic keratoses
Alembic Pharmaceuticals receives US FDA tentative approval for Macitentan tablets, 10 mg
The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Opsumit tablets, 10 mg, of…
Alembic Pharma receives US FDA tentative approval for Fesoterodine Fumarate extended-release tablets
The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Toviaz extended-release…
Alembic Pharmaceuticals receives US FDA tentative approval for Dronedarone tablets
Dronedarone is indicated to reduce the risk of hospitalisation for atrial fibrillation in patients in sinus rhythm with a history…
Alembic Pharmaceuticals receives US FDA tentative approval for Selexipag tablets
The tablets are therapeutically equivalent to Uptravi tablets of Actelion Pharmaceuticals
Alembic Pharmaceuticals’s joint venture Aleor Dermaceuticals receives US FDA final approval…
The approved ANDA is therapeutically equivalent to the Reference Listed Drug product (RLD), Bactroban Cream, 2% of SmithKline…