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CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:202091Orig1s000
SUMMARY REVIEW Cross Discipline Team Leader Reviews noted in the introduction, Lupin Pharmaceuticals, Inc. submitted this
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What is 202091orig1s000 - fda?
202091orig1s000 - fda is a form required by the FDA for submitting information related to original submissions.
Who is required to file 202091orig1s000 - fda?
All applicants submitting original applications to the FDA are required to file 202091orig1s000 - fda.
How to fill out 202091orig1s000 - fda?
The form can be filled out electronically on the FDA's website or submitted through the FDA's electronic submission gateway.
What is the purpose of 202091orig1s000 - fda?
The purpose of 202091orig1s000 - fda is to provide the FDA with necessary information for the review of original submissions.
What information must be reported on 202091orig1s000 - fda?
Information such as applicant details, product information, clinical trial data, and labeling information must be reported on 202091orig1s000 - fda.
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