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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 203441 NDA APPROVAL NPS Pharmaceuticals, Inc. Attention: Sandra Cantrell, MA, PhD Vice President, Regulatory
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What is gattex teduglutide rdna origin?
Gattex teduglutide rdna origin is a medication used for the treatment of adults with short bowel syndrome.
Who is required to file gattex teduglutide rdna origin?
Only pharmaceutical companies or manufacturers who produce and distribute gattex teduglutide rdna origin need to file it.
How to fill out gattex teduglutide rdna origin?
To fill out gattex teduglutide rdna origin, the pharmaceutical company or manufacturer must provide detailed information about the medication, including its manufacturing process, composition, and safety profiles.
What is the purpose of gattex teduglutide rdna origin?
The purpose of gattex teduglutide rdna origin is to help manage and improve the condition of adults with short bowel syndrome by providing them with a synthetic form of human glucagon-like peptide-2 (GLP-2).
What information must be reported on gattex teduglutide rdna origin?
The pharmaceutical company or manufacturer must report detailed information about the medication's manufacturing process, quality control measures, composition, active ingredients, potential side effects, and any known drug interactions.
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