US FDA approves Lupin’s Mirabegron extended-release tablets
The product will be manufactured at Lupin’s facility in Nagpur
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ANDA
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…
Unichem Laboratories receives US FDA approval for divalproex sodium
These are the generic equivalent of Depakote ER (Divalproex Sodium) extended-release tablets 250 mg and 500 mg, of AbbVie Inc
Granules Pharmaceuticals receives ANDA approval for Amphetamine mixed salts from US FDA
The product is bioequivalent to the Reference Listed Drug (RLD) product Adderall of Teva Women’s Health Inc, and would be…
Granules India gets US FDA nod for generic Prazosin Hydrochloride capsules
These capsules are bioequivalent to the reference listed drug product, Mini plus capsules 1mg, 2mg and 5mg of Pfizer Inc
Alembic Pharmaceuticals announces US FDA final approval for formoterol fumarate inhalation solution
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
Alembic Pharma gets USFDA final approval for Doxepin Hydrochloride Capsules
Doxepin Hydrochloride Capsules are recommended for the treatment of depression and anxiety
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
Granules India gets US FDA approval for Potassium Chloride ER Capsules
Potassium Chloride is indicated for the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis…