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CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for:APPLICATION NUMBER:NDA 022309/S001 Trade Name: 1.62%Generic Name: Gel Sponsor:Abbott Products, Inc. Approval Date: 09/07/2012 Indications:
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What is nda 022309s-001?
NDA 022309s-001 is a specific form submitted to the FDA for a new drug application.
Who is required to file nda 022309s-001?
Any pharmaceutical company seeking approval for a new drug product.
How to fill out nda 022309s-001?
The form must be completed with detailed information about the drug, clinical trials, and safety data.
What is the purpose of nda 022309s-001?
The purpose is to obtain FDA approval for marketing a new drug in the United States.
What information must be reported on nda 022309s-001?
Information on drug composition, manufacturing process, clinical trial results, and safety data.
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