Get the free NDA 211843: THIOLA EC ()

CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:211843Orig1s000 PRODUCT QUALITY REVIEW(S)Oil#_Cf1JiliWQUALITY ASSESSMENT 211843: THINLY EC () Delayed Release Tablets OPQ Integrated Quality

How to fill out nda 211843 thiola ec

How to fill out nda 211843 thiola ec

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What is nda 211843 thiola ec?

NDA 211843 Thiola EC refers to a New Drug Application for Thiola EC, a medication used to manage cystinuria and prevent kidney stones.

Who is required to file nda 211843 thiola ec?

The manufacturer or sponsor of Thiola EC, typically a pharmaceutical company, is required to file NDA 211843.

How to fill out nda 211843 thiola ec?

To fill out NDA 211843 Thiola EC, the applicant must provide detailed information including drug composition, production process, clinical trial data, labeling, and proposed use.

What is the purpose of nda 211843 thiola ec?

The purpose of NDA 211843 Thiola EC is to seek approval from the FDA for the marketing of the drug, ensuring it is safe and effective for public use.

What information must be reported on nda 211843 thiola ec?

Information reported in NDA 211843 must include chemistry, manufacturing and controls (CMC), pharmacology, clinical efficacy and safety data, labeling, and proposed usage.