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Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance
… / 30% 05446-0970-03 CIPROFLOXACIN / SULFACETAMIDE SODIUM / AMPHOTERICIN B 30MG / 50MG / 5MG 05446-1633-01 CIPROFLOXACIN / SULFACETAMIDE SODIUM / AMPHOTERICIN B / HYDROCORTISONE 30MG / 50MG / 5MG / 25MG …
Antifungal Susceptibility Test Interpretive Criteria
https://www.fda.gov/drugs/development-resources/antifungal-susceptibility-test-interpretive-criteria
… Exceptions or Additions to CLSI M27M44S Standards Amphotericin B* Injection No No Anidulafungin Injection Yes No Caspofungin …
Advancing Generic Drug Development: Translating Science to Approval 2023 - 09/13/2023
… PharmD Senior Staff Fellow DB II | OB | OGD | CDER Amphotericin B Liposome: Changes Identified.pdf Bin Qin, PhD Senior …
2021 First Generic Drug Approvals
… hypotensive despite fluids and catecholamines 91 212514 Amphotericin B Liposome for Injection , 50 mg/vial Single-Dose Vial Sun Pharmaceutical Industries Limited AmBisome (Amphotericin B) Liposome for Injection , 50 mg/vial …
Competitive Generic Therapy Approvals
… also eligible for CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act. This list will be updated on a … N/A 179 AmBisome Liposome, NDA 050740 214010 Eugia US LLC Amphotericin B Injection, 50 mg/vial Single-Dose Vial … NDA 050740 212514 Sun Pharmaceutical Industries Inc. Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose …
Drug Quality Sampling and Testing Programs
… Hand Sanitizer Refrasia Care Hand Sanitizer GEL Lemon-X d.b.a. Bevolution Group Assay, Impurities Hand Sanitizer … Compounding Initiative Passed Test PREGNENOLONE API B&B PHARMACEUTICALS, INC. Elemental Analysis Compounding … Consumer complaint (ineffectiveness) Passed Test Amphotericin B Generic For Injection X-Gen Pharmaceuticals, …