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https - accessdata.fda.gov

www.accessdata.fda.gov › cfdocs › cfrl
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Drugs - FDA

www.fda.gov › drugs
Search our databases: Drugs@FDA. Find information about most FDA-approved prescription, generic, and over-the-counter drug products.
FDA Approves First Nalmefene... · FDA Approves First Nasal... · Video series
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Devices@FDA Database - accessdata.fda.gov

www.accessdata.fda.gov › scripts › cdrh
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[PDF] OZEMPIC (semaglutide) injection, for subcutaneous use

www.accessdata.fda.gov › label
The most common adverse reactions, reported in ≥5% of patients treated with. OZEMPIC are: nausea, vomiting, diarrhea, abdominal pain and constipation. (6.1). To ...
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[PDF] Wegovy (semaglutide) injection - accessdata.fda.gov

www.accessdata.fda.gov › label
Most common adverse reactions (incidence ≥ 5%) in adults or pediatric patients aged 12 years and older are: nausea, diarrhea, vomiting, constipation, abdominal.
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510(k) Premarket Notification - accessdata.fda.gov

www.accessdata.fda.gov › cfpmn › pmn
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, ...
Print · De Novo Classification · Downloadable 510(k) Files
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[PDF] ZEPBOUND (tirzepatide) - accessdata.fda.gov

www.accessdata.fda.gov › label
WARNING: RISK OF THYROID C-CELL TUMORS. See full prescribing information for complete boxed warning. • In rats, tirzepatide causes thyroid C-cell tumors.
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Search for FDA Guidance Documents

www.fda.gov › regulatory-information
You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, ...
Clinical Trials Guidance... · Product-Specific Guidances · Class II Special Controls...
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