Drugs

ECH Document Type

FDA Data Element Number.

CDER Data Element Number. C-GEN-10302

Data Element Name. ECH Document Type

Description. ECH Document Type describes the major classification of correspondence that the electronic charge and history card will track.

Source. ECH users group.

Relationship.

FDA Specifications.

CDER Specifications. ECH Document Type shall consist of an alphanumeric term which has a maximum length restricted to 60 characters, and a corresponding alphanumeric code with a maximum length of 3 characters. The first character, either "I" or "N" refers to whether the code applies to IND's or NDA's, respectively.

FDA Approved Date.

CDER Approved Date. February 1, 2000

FDA Revised Date.

CDER Revised Date.

Data Values.

NAME DEFINITION FDA CODE
NDA Incoming Correspondence Literal NC
IND Incoming Correspondence Literal IC
NDA Internally Generated Correspondence For Archiving Literal NIN
IND Internally Generated Correspondence For Archiving Literal IIN
NDA Internally Generated Outgoing Correspondence Literal NUX
IND Internally Generated Outgoing Correspondence Literal IUX
NDA Adverse Experience Reports Literal ND
NDA Final Printed Labeling After Approval Literal NFA

 

Page Last Updated: 12/07/2014
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