FDA Approves Unknown Drug — MYLAN
# FDA Approves Mylan ANDA Application Mylan received FDA approval for ANDA218851 on March 5, 2026, expanding the company's generic drug portfolio and positioning it to capture add…
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# FDA Approves Mylan ANDA Application Mylan received FDA approval for ANDA218851 on March 5, 2026, expanding the company's generic drug portfolio and positioning it to capture add…
# FDA Approves Glenmark Pharmaceuticals' Generic Olanzapine Injection, Expanding Long-Acting Antipsychotic Market The FDA has approved Glenmark Pharmaceuticals Inc.'s abbreviated …
# FDA Approves Advagen Pharma's Generic Children's Ibuprofen Advagen Pharma Ltd. received FDA approval for its generic Children's Ibuprofen oral formulation (ANDA220239) on March …
# FDA Approves Zydus Pharmaceuticals' Generic Calcitonin Salmon Injection The FDA has approved Zydus Pharmaceuticals USA Inc.'s generic calcitonin salmon intramuscular injection (…
# FDA Approves ASPIRO's Generic Drug Application ASPIRO has received FDA approval for its abbreviated new drug application (ANDA 220124), expanding the company's generic pharmaceu…
# FDA Approves Generic Moxifloxacin ANDA from Macleods Pharmaceuticals Macleods Pharmaceuticals Limited has received FDA approval for its generic moxifloxacin hydrochloride oral f…
# FDA Approves Epic Pharma's Generic Drug Application Epic Pharma LLC has received FDA approval for an abbreviated new drug application (ANDA 219556), marking another addition to …
# FDA Approves Janssen Product, Expanding Company's Portfolio Janssen Products received FDA approval for a new therapeutic agent under NDA 220092, potentially strengthening the ph…
# FDA Approves Ascendis Pharma's YUVIWEL (navepegritide), Marking Entry Into Growth Hormone Deficiency Market Ascendis Pharma Endocrinology, Inc. received FDA approval for YUVIWEL…
# FDA Approves Caplin Steriles' Intravenous Desmopressin Acetate Caplin Steriles Limited has received FDA approval for its generic intravenous desmopressin acetate formulation (AN…
Macleods Pharmaceuticals Limited announced the FDA’s approval of its generic Diltiazem Hydrochloride oral tablets on February 27, 2026, facilitating the company’s expansion into th…
# FDA Approves ANDA for SinoTherapeutics Inc SinoTherapeutics Inc has received FDA approval for ANDA220454, marking the company's entry into the generic drug market and positionin…
# FDA Approves Viona Pharmaceuticals' Generic Dapsone Viona Pharmaceuticals Inc. received FDA approval for its generic dapsone oral formulation, expanding treatment options for pa…
# FDA Approves Zydus Lifesciences' Generic Ivermectin Oral Formulation Zydus Lifesciences Limited received FDA approval for its generic ivermectin oral formulation, expanding the …
# FDA Approves Aurobindo Pharma's Generic Everolimus, Expanding Competitive Landscape for Immunosuppressant Market The U.S. Food and Drug Administration has approved Aurobindo Pha…
# FDA Approves Dr. Reddy's Generic Drug Application Dr. Reddy's Laboratories has received FDA approval for ANDA220315, marking another addition to the company's generic drug portf…
# FDA Approves APPCO's Generic Drug Application APPCO has received FDA approval for an abbreviated new drug application (ANDA 220329), expanding its generic pharmaceutical portfol…
# FDA Approves Generic Cetirizine Hydrochloride for Advagen Pharma Ltd. Advagen Pharma Ltd. has received FDA approval for its generic cetirizine hydrochloride oral formulation (AN…
# FDA Approves ANDA for Yichang Humanwell The FDA has approved ANDA219518 for Yichang Humanwell, marking the company's entry into the U.S. generic drug market and potentially incr…
# FDA Approves Generic Brivaracetam Intravenous Formulation Micro Labs Limited has received FDA approval for a generic intravenous brivaracetam formulation (ANDA214880), marking a…