Septodont Inc. has received FDA approval for the Flavalta submucosal lidocaine and epinephrine system, a launch set for March 19, 2026, which is expec...
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# FDA Approves Glenmark Therapeutics' Generic Fluticasone Propionate Nasal Spray The FDA has approved Glenmark Therapeutics Inc.'s abbreviated new dr...
Dr. Reddy’s Laboratories Inc. announced the FDA approval of its oral Eltrombopag Olamine (ANDA219121), which is slated for March 16, 2026, and positio...
# FDA Approves Generic Citalopram for Aurobindo Pharma Aurobindo Pharma Limited has received FDA approval for its generic citalopram hydrobromide ora...
# FDA Approves Generic Drug Application for Hetero Labs Hetero Labs Ltd III received FDA approval for an abbreviated new drug application (ANDA218264...
# FDA Approves Generic Liraglutide from Biocon Pharma Inc. Biocon Pharma Inc. has received FDA approval for its generic formulation of liraglutide (A...
# FDA Approves Zydus Lifesciences' Generic Cevimeline Hydrochloride Zydus Lifesciences Limited has received FDA approval for its generic cevimeline h...
# FDA Approves DIFGEN Pharms Generic Drug Application DIFGEN Pharms has received FDA approval for its abbreviated new drug application (ANDA 219997),...
The FDA has granted approval to YICHANG HUMANWELL for a new Abbreviated New Drug Application, extending the company’s commercial footprint in the gene...
# FDA Approves E5 Pharma ANDA Application E5 Pharma has received FDA approval for ANDA216808, marking a significant expansion of the company's generi...
# FDA Approves KNACK's Generic Drug Application KNACK has received FDA approval for its abbreviated new drug application (ANDA 218675), positioning t...
# FDA Approves ANDA for Steranco Healthcare Steranco Healthcare has received FDA approval for an abbreviated new drug application (ANDA220281), posit...
CONTRACT PHARMACAL today announced that the FDA has granted approval for its ANDA #219603, a milestone likely to boost the company's generic revenue s...
# FDA Approves Solco Healthcare's Generic Gabapentin The FDA has approved Solco Healthcare US, LLC's abbreviated new drug application for generic gab...
# FDA Approves Aurobindo Pharma Generic Drug Application The U.S. Food and Drug Administration has approved Aurobindo Pharma Ltd.'s abbreviated new d...
# FDA Approves Mylan ANDA Application Mylan received FDA approval for ANDA218851 on March 5, 2026, expanding the company's generic drug portfolio and...
# FDA Approves Glenmark Pharmaceuticals' Generic Olanzapine Injection, Expanding Long-Acting Antipsychotic Market The FDA has approved Glenmark Pharm...
# FDA Approves Advagen Pharma's Generic Children's Ibuprofen Advagen Pharma Ltd. received FDA approval for its generic Children's Ibuprofen oral form...
# FDA Approves Zydus Pharmaceuticals' Generic Calcitonin Salmon Injection The FDA has approved Zydus Pharmaceuticals USA Inc.'s generic calcitonin sa...
# FDA Approves ASPIRO's Generic Drug Application ASPIRO has received FDA approval for its abbreviated new drug application (ANDA 220124), expanding t...