IUPHAR/BPS Guide to PHARMACOLOGY. DrugBank. Drug Approvals and Databases > Drugs@FDA Glossary of Terms. Abbreviated New Drug Application (ANDA) An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.
Drugs Dictionary,Pharmaceutical Dictionary,Drugs Glossary,Pharmaceutical Drugs Glossary,Pharmaceutical Drugs Dictionary. Sulfacetamide Sodium ophthalmic: indications, and side effects. For sure the human eye, as a very sensitive organ, is majorly vulnerable to lots of infections and irritation.
This is antagonized by using one or more medicaments from a wide variety. One of those medicaments is the sulfacetamide sodium eye drops. It is a very renowned antibacterial agent administered in the eye to counteract bacterial infections as conjunctivitis. Also, sulfacetamide sodium is available in other dosage forms like lotions and ointments. PSA Pilot.
Antibiotics. Anti-depressants. Birth Control. Insulin. NSAIDs. Steroids.