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PDF center for drug evaluation and research application number - FDA 2025

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The document is a clinical pharmacology and biopharmaceutics review for the New Drug Application (NDA) 21-201 concerning Aethoxysklerol (polidocanol), intended for the treatment of varicose veins in the lower extremities. It details the drug's formulation, proposed dosages, and indications, as well as the history of submissions and resubmissions due to previous deficiencies in pharmacokinetic data. The review highlights significant findings from clinical trials, including issues with bioavailability studies, pharmacokinetics, and efficacy compared to other treatments. Ultimately, it concludes that while safety data appears acceptable, efficacy has not been sufficiently demonstrated to warrant approval.

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What is the format of FDA NDC number?

Proper billing of a National Drug Code (NDC) requires an 11-digit number in a 5-4-2 format. Converting National Drug Code (NDC) from a 10-digit to an 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.

What is the FDA application number?

This six digit number is assigned by 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. In Drugs@FDA, you can find the NDA number under the column named FDA Application.

How many digits is an FDA registration number?

After the U.S. Agent has accepted their designation and once this information is submitted, reviewed, and accepted by FDA, you will then be given an 11-digit food facility registration number and are one step closer to distributing products throughout the United States.

How to get an IND number?

File the Initial IND and Receive an IND Number The initial IND submission should be accompanied by a cover letter, a Form FDA 1571 (see instructions) and a ClinicalTrials.Gov Certification of Compliance - FDA 3674. ( All must be submitted in triplicate (an original and two photocopies):

What is the format of FDA application number?

A pre-assigned application number is a unique six-digit number, e.g., 012345, assigned to sponsors to enable them to identify their application. The FDA requires that you use this number any time you submit an eCTD application.

What is the difference between CDER and CDRH?

The abbreviated new drug application (ANDA) number is a six-digit number assigned by FDA staff to each ANDA. An ANDA is an application containing data for the review and ultimate approval of a generic drug product by the Food Drug Administration.

PDF center for drug evaluation and research application number - FDA 2025

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