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Can a drug have new drug application and an abbreviated new drug application number be the same?
Wiki User
∙ 11y ago
No, a drug can not have new drug application and an abbreviated drug application number can be NOT the same. Source: Experience.
Wiki User
∙ 11y ago
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What is the difference between ANDA and NDA?
NDA means New Drug Application. This application is available at the Food and Drug Administration (FDA). When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet the FDA's requirements for marketing approval, the sponsor submits to the FDA a new drug application (NDA). In other words, when a pharmaceutical company creates a new drug, the company must contact the FDA and demonstrate that the new drug has a particular quality and that the drug is safe and effective. In this case, the pharmaceutical company will have to fill out a new drug application (NDA). If the NDA is approved, then the product may be marketed in the United States. The application must contain data from specific technical viewpoints for review. The review is a comprehensive analysis of clinical trial data and other information prepared by the FDA drug application reviewers. A review is divided into sections on medical analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology, statistics, and microbiology. For internal tracking purposes, all NDA applications are assigned an NDA number. The NDA number is a six-digit number assigned by the FDA staff to each application for approval to market a new drug in the United States. A drug can have more than one application number if it has different dosage forms or routes of administration. ANDA means Abbreviated New Drug Application. This application is available at the Food and Drug Administration (FDA). An abbreviated new drug application (ANDA) contains data that, when submitted to the FDA, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are 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 original drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the public. For internal tracking purposes, all ANDA applications are assigned an ANDA number. The ANDA number is a six-digit number assigned by the FDA staff to each application for approval to market a generic drug in the United States. A generic drug must be the same as the brand-name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Before approving a generic drug product, the FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand-name drug. The FDA bases evaluations of substitutability or "therapeutic equivalence" of generic drugs on scientific evaluations.
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Which number represents the greatest mass 9000mg 400g 0.04kg or 0.009kg?
The prefix "milli", abbreviated as "m" in "mg", means in number terms 10-3, and the prefix "kilo" abbreviated as "k" in "kg", means in number terms 103. Therefore, 9000 mg is the same as 9 grams, 0.04 kg is the same as 40 grams, and 0.009 kg is the same as 9 grams. Clearly, with all the units now the same, the largest mass among those listed is 400g.
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