Delaware Abbreviated New Drug Application (AND) is the legal document submitted to the U.S. Food and Drug Administration (FDA) by a pharmaceutical company to seek approval to market a generic drug in the United States. Andes may be submitted to the FDA for the approval of generic versions of both prescription and over-the-counter (OTC) drugs. The AND contains information about the generic drug's active ingredient, manufacturing process, bioequivalence, safety, effectiveness, and labeling. Delaware Abbreviated New Drug Applications (AND) come in two types: 505(j) AND 505(b)(2) AND. A 505(j) AND Ais an application for approval of a generic version of a previously approved drug. A 505(b)(2) AND Ais an application for approval of a new drug with certain components being reviewed through the 505(j) pathway. Both types of the Andes must demonstrate that the generic drug is bioequivalent in terms of safety, effectiveness, and performance to the brand-name drug.
Delaware Abbreviated New Drug Application (ANDA)
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In order to submit a complete ANDA, applicants should review the following forms and prepare all that are required for your specific application. Filing Review of ANDAs MAPP including filing checklist (PDF - 521KB) Form FDA-356h: Application to Market a New Drug, Biologic, or Antibiotic Drug for Human Use (PDF - 2.3MB)
An ANDA lists the new drug's established name, trade name (if any), chemical name, dosage form(s), and strength(s), route of administration, and proposed use. The ANDA asks for the name of the listed drug product to which the proposed generic is an equivalent.
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
An Abbreviated New Drug Application (ANDA) contains data which is submitted to the FDA for the review and potential approval of a generic drug product whereas a New Drug Application (NDA) is the application through which sponsors formally propose the approval of a new pharmaceutical drug.
STEPS ?Filling review ?Coordination of generic drug review process. ?Bioequivalence review process. ?Chemistry review process. ?Labeling review process.
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
Generic pharmaceutical companies will typically file an ANDA when the patent protection period of a brand-name drug is about to expire.
Standard Original ANDAs Within 10 months of submission date.