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D. Office of New Drug Quality Assessment Electronic Signature Yong Hu -S Digitally signed by Yong Hu -S DN c US o U.S. Government ou HHS ou FDA ou People cn Yong Hu -S 0. 4. 1 Control of Excipients Inhalation Powder The only excipient used in the product is The excipient complies with the USP/NF monograph for lactose monohydrate. VIPULCHANDRA N DHOLAKIA ONDQA Initial Quality Assessment IQA ADDENDUM IQA ADDENDUM 2. DATES AND GOALS Letter Date 05-MAY-2014 Name USAN Route of Administration...

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205636orig1s000 - fda is a form required by the FDA for certain pharmaceutical submissions.

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Pharmaceutical companies and manufacturers are required to file 205636orig1s000 - fda.

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205636orig1s000 - fda can be filled out online on the FDA's official website or submitted through the Electronic Submissions Gateway.

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The purpose of 205636orig1s000 - fda is to provide the FDA with important information about pharmaceutical products for review and approval.

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