Get the free Drug Approval Package: Brand Name (Generic Name) NDA # - accessdata fda
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CENTER FOR DRUG EVALUATION AND
RESEARCHAPPLICATION NUMBER:204410Orig1s000OTHER REVIEW(S)NDA 204410 Suit (macitentan) PM OverviewRHPM NDA Overview
October 18, 2013,
Suit (macitentan) Tablets
NDA 204410
Applicant:
Classification:Acte
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What is drug approval package brand?
The drug approval package brand is the official branding or trademark associated with a specific drug product.
Who is required to file drug approval package brand?
The manufacturer or sponsor of the drug product is required to file the drug approval package brand.
How to fill out drug approval package brand?
The drug approval package brand can be filled out by submitting the necessary forms and documentation to the regulatory authorities.
What is the purpose of drug approval package brand?
The purpose of the drug approval package brand is to uniquely identify and distinguish a specific drug product in the market.
What information must be reported on drug approval package brand?
The drug approval package brand must include the product name, manufacturer information, active ingredients, and any specific branding or logos.
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