Get Delayed Release Tablets Description - Accessdata Fda

Filling out the Delayed Release Tablets DESCRIPTION form is essential for proper documentation and regulatory compliance. This guide provides a step-by-step approach to assist users in filling out this important document accurately and efficiently.

Follow the steps to complete the form successfully.

1. Click the ‘Get Form’ button to access the document. This will enable you to download and open the form in your preferred editor.
2. Begin by entering the product name at the designated field. Ensure accuracy as this is critical for identification and regulatory purposes. In this case, enter '™ ()'.
3. Proceed to fill in the dosage information. Specify that each tablet contains '1.2g 5-aminosalicylic acid (5-ASA)'. This information is crucial as it relates to the active ingredient.
4. Complete the section detailing the inactive ingredients. List all components such as 'sodium carboxymethylcellulose, carnauba wax, stearic acid, etc.' as mentioned in the document, ensuring to include all names without omissions.
5. Address the clinical pharmacology section by briefly summarizing the mechanism of action. State that the mechanism is not fully understood but involves blocking cyclooxygenase and inhibiting prostaglandin production.
6. Fill in the pharmacokinetics section. Include necessary data such as absorption rates and metabolism information. For instance, indicate that total absorption is approximately 21-22% and mention the significance of renal elimination.
7. In the contraindications section, clearly indicate any hypersensitivities and the populations that may require caution, ensuring clarity for future reference.
8. Review the adverse reactions listed to ensure completeness. Mention common responses such as headache and flatulence as well as any serious reactions that could require attention.
9. Finally, ensure all entered information is double-checked for accuracy. After verifying the form, proceed to save your changes. You may also choose to download, print, or share the completed document as necessary.

Complete your documents online efficiently and ensure regulatory compliance.