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CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 208434Orig1s000 Trade Name: License capsule, 150 mg. Generic Name: Electing Sponsor: Hoffmann Roche, Incorporated
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Who needs approval package for?

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Approval package is for obtaining authorization or consent for a certain action or decision.
Entities or individuals who need approval or authorization for a specific purpose.
Approval package can be filled out by providing all required information and documentation as per guidelines.
The purpose of approval package is to ensure that all necessary approvals are obtained before proceeding with a certain action or decision.
Information such as details of the action or decision requiring approval, supporting documentation, and any relevant background information.
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