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Re: JLH2 post# 49993

Tuesday, 01/16/2018 8:11:25 PM

Tuesday, January 16, 2018 8:11:25 PM

Post# of 58837
That is a small portion of the information required in the DMF submission.
For example and in APDN’s case, they must submit the trade names and manufacturers to which they will apply their excipients.

Section 510 of the Act and 21 CFR Part 207 set forth registration information required to be submitted by domestic and foreign drug establishments. (See sections 510(b), (c), (d), and (i) of the Act and 21 CFR 207.25(a), 21 CFR 207.26, and 21 CFR 207.40). Under these provisions, all registrants must provide the name and full address of each establishment, all trade names used by the establishment, the kind of ownership or operation (e.g., individually owned, partnership, or corporation), and the name of the owner or operator (including in the case of a partnership the name of each partner, and in the case of a corporation, the name and title of each corporate officer and director and the State of incorporation).
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  • 5Y
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