Get 022396orig1s000 - Food And Drug Administration - Accessdata Fda

This guide provides users with comprehensive instructions on how to fill out the 022396Orig1s000 form associated with the Food and Drug Administration. Follow these detailed steps to ensure a smooth and effective completion of the form online.

Follow the steps to successfully complete the form online.

1. Click the ‘Get Form’ button to obtain the form and open it in the editor.
2. Provide the application number: Enter '022396Orig1s000' in the designated field to identify the application.
3. Complete the trade name section: Fill in 'Dyloject Injection' as indicated to specify the product being reviewed.
4. Enter the generic name: Type 'Diclofenac Sodium' to clarify the active ingredient in the application.
5. Include the sponsor information: Input 'Javelin Pharmaceuticals, Inc.' in the appropriate section to identify the manufacturer.
6. Specify the approval date: Write 'December 23, 2014' to record the date of approval for the application.
7. Detail the indications: Instruct users to write the specific use of Dyloject, which is for the management of mild to moderate pain and moderate to severe pain.
8. Fill in all required sections relevant to labeling, reviews, and assessments as per the guidelines provided in the form.
9. Review all entries for accuracy: Ensure all information entered is correct before finalizing the form.
10. Save your changes, and use options to download, print, or share the form as needed.

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