Generic drug products Applications

The holder of the generic drug product application uses the existing tolerance, marker residue, target... 

An ANDA contains data that, when submitted to the FDA s CDER, Office of Generic Drugs, provide for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low-cost alternative to the American public. 

Abbreviated applications should be sent to the Division of Generic Drug Products. 

Application review and ultimate approval of a generic drug product. This document does... 

The generic drug product requires an abbreviated new drug application (ANDA) for approval by the FDA and may be marketed after patent expiration of... 

The ANDA is required to market a generic drug product. It is the application for duplicating a drug product that the FDA has previously approved. The submission requires CMC data. A portion of that information may be derived... 

For new drug products with little or no effective patent life, generic firms are prohibited from filing an abbreviated new drug application within the first 5 years of the product life. Most European countries prohibit such filing within the first 10 years of market life. 

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