The company said the
Abbreviated New Drug Application (ANDA) for Dronabinol Capsules USP, 2.5 mg, 5 mg and 10 mg is the therapeutic equivalent to the reference listed drug, Marinol Capsules 2.5 mg, 5 mg and 10 mg from AbbVie Inc.
Generic pharmaceutical company Amerigen Pharmaceuticals Limited revealed on Tuesday the receipt of final approval from the US Food and Drug Administration for its
Abbreviated New Drug Application (ANDA) for cyclophosphamide capsules in 25mg and 50mg.
M2 PHARMA-March 21, 2018-Amerigen wins US FDA final approval for
Abbreviated New Drug Application for cyclophosphamide capsules to treat cancers
The United States Food and Drug Administration (US FDA) has sanctioned TWi Pharmaceuticals on its
Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride Tablets USP, 23 mg, the generic equivalent to Eisai Inc.
has received approval from the Food and Drag Administration for its
Abbreviated New Drug Application for over-the-counter ranitidine, 150 mg (regular and cool mint), a genetic version of Zantac 150, which is indicated for the relief of heartburn associated with acid indigestion and sour stomach, and for the prevention of heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages.
FDA approval on its
Abbreviated New Drug Application for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg and has immediately initiated commercialization activities.
Glenmark Pharmaceuticals announced that Glenmark Generics Inc., USA, the subsidiary of Glenmark Generics, has won final approval from the United States Food and Drug Administration (US FDA) for its
abbreviated new drug application (ANDA) for Fluocinonide Cream USP 0.1%, the generic version of Vanos Cream by Medicis.
The United States Food and Drug Administration (FDA) has granted tentative approval to Impax Laboratories Inc (NASDAQ: IPXL), a specialty pharmaceutical company, for its
Abbreviated New Drug Application (ANDA) for the generic version of Coreg CR (carvedilol phosphate) extended-release capsules, 10, 20, 40 and 80 mg, it was reported on Friday.
The US Food and Drug Administration has given final approval for the
Abbreviated New Drug Application (ANDA), being manufactured and supplied by its parent company, Laboratorios Dr.
Watson Laboratories, a subsidiary of Watson Pharmaceuticals Inc., has filed an
Abbreviated New Drug Application (ANDA) with the Food and Drug Administration, seeking approval to market a generic version of Combigan.
FDA for its
Abbreviated New Drug Application for this product, which is indicated for the treatment of dementia associated with mild, moderate and severe Alzheimer's disease and the treatment of mild to moderate dementia associated with Parkinson's disease.
The United States Food and Drug Administration (FDA) has approved the
Abbreviated New Drug Application for United States-based Impax Laboratories, Incorporated's (NASDAQ: IPXL) generic version of Renvela[R] (sevelamer carbonate) tablets, 800 mg, it was reported on Monday.
