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Dose levels. AUC values for PTBI exceeded that of E3810 with the exception of the low-dose group on pp day 7. Ke Zhang TABLE OF CONTENTS EXECUTIVE SUMMARY. 3 DRUG INFORMATION. 6 PK/ADME.. 10 TOXICOKINETICS. 11 GENERAL TOXICOLOGY. 03/23/2013 PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION Application number Supporting document/s 204 736 Applicant s letter date September 27 2012 CDER stamp date Product Rabeprazole / Indication Gastroesophageal Reflux Disease GERD Applicant Eisai Inc....

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1. Individuals or organizations who are required by the FDA (Food and Drug Administration) to provide information or documentation using the form 204736orig1s000.
2. Those involved in the regulation, approval, or study of food and drug products may need to fill out this form as a part of their regulatory or compliance obligations.
3. Manufacturers, distributors, importers, or exporters of food or drug products may also require the completion of this form for various regulatory purposes.

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What is 204736orig1s000 - fda?

204736orig1s000 - fda is a form required by the FDA for certain drug approvals.

Who is required to file 204736orig1s000 - fda?

Pharmaceutical companies seeking FDA approval for a new drug are required to file 204736orig1s000.

How to fill out 204736orig1s000 - fda?

The form must be filled out completely and accurately with all required information about the drug being submitted for approval.

What is the purpose of 204736orig1s000 - fda?

The purpose of 204736orig1s000 is to provide the FDA with necessary information to evaluate the safety and efficacy of a new drug.

What information must be reported on 204736orig1s000 - fda?

Information such as drug composition, preclinical and clinical trial data, proposed labeling, and potential risks must be reported on 204736orig1s000.