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CENTER FOR DRUG EVALUATION AND RESEARCH
Approval Package for:
APPLICATION NUMBER:211672Orig1s000
211673Orig1s000
Trade Name:DELTA tablets, 600 mg
DELTA injection, 150 generic or Proper
Name:lefamulinSponsor:Sabrina
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What is approval package - accessdatafdagov?
The approval package on accessdata.fda.gov is a set of documents and information required for the approval of a medical product.
Who is required to file approval package - accessdatafdagov?
Manufacturers or sponsors of medical products are required to file the approval package on accessdata.fda.gov.
How to fill out approval package - accessdatafdagov?
The approval package on accessdata.fda.gov can be filled out electronically using the FDA's electronic submission system.
What is the purpose of approval package - accessdatafdagov?
The purpose of the approval package on accessdata.fda.gov is to provide the FDA with the necessary information to evaluate the safety and effectiveness of a medical product.
What information must be reported on approval package - accessdatafdagov?
The approval package on accessdata.fda.gov must include information on the product's ingredients, manufacturing process, clinical trial data, and proposed labeling.
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