Drugs

INVAS Volume Type

FDA Data Element Number.

CDER Data Element Number. C-GEN-10307

Data Element Name. INVAS Volume Type

Description. INVAS Volume Type describes the major categories of submissions received by the Center from sponsors and applicants.

Source.

Relationship.

FDA Specifications. No specifications.

CDER Specifications. INVAS Volume Type shall consist of a descriptive term with a maximum length of 60 alphanumeric characters, and code for those terms with a maximum length of 2 alphanumeric characters. The first character (i.e., D, I, or N) relates to a Drug Master File (DMF), Investigational New Drug Application (IND), or New Drug Application (NDA).

FDA Approved Date.

CDER Approved Date. February 1, 2000

FDA Revised Date.

CDER Revised Date.

Data Values.

NAME DEFINITION FDA CODE
DMF ORIGINAL PAPER COPY Literal DA
DMF DUPLICATE PAPER COPY Literal DB
DMF TAPE BACKUP OF ELECTRONIC COPY FOR DIMS Literal DL
DMF TAPE BACKUP OF ELECTRONIC COPY FOR EDR Literal DR
DMF TEMPORARY JACKET Literal DT
DMF VIDEO Literal DV
DMF ORIGINAL ELECTRONIC COPY Literal DX
DMF DUPLICATE ELECTRONIC COPY Literal DZ
IND ARCHIVAL PAPER COPY Literal IA
IND CHEMIST PAPER COPY Literal IB
IND PHARMACOKINETICS PAPER COPY Literal IP
IND PHARMACOLOGIST PAPER COPY Literal IC
IND REVIEW DIVISION PAPER FILE Literal ID
IND STATISTICS PAPER COPY Literal IS
IND TAPE BACKUP OF ELECTRONIC COPY FOR DIMS Literal IL
IND TAPE BACKUP OF ELECTRONIC COPY FOR EDR Literal IR
IND TEMPORARY JACKET Literal IT
IND VIDEO Literal IV
IND MICROBIOLOGIST PAPER COPY Literal IW
IND ORIGINAL ELECTRONIC COPY Literal IX
IND DUPLICATE ELECTRONIC COPY Literal IZ
NDA/ANDA ARCHIVAL PAPER COPY Literal NA
NDA/ANDA CHEMIST PAPER COPY Literal NB
NDA/ANDA PHARMACOLOGIST PAPER COPY Literal NC
NDA/ANDA REVIEW DIVISION PAPER FILE Literal ND
NDA/ANDA FIELD PAPER COPY Literal NF
NDA/ANDA ORIGINAL PAPER COPY OF ANY MARKETING MATERIALS OTHER THAN FORM 2253 Literal NG
NDA/ANDA ORIGINAL PAPER COPY OF FORM 2253 Literal NH
NDA/ANDA ACTION PACKAGE Literal NK
NDA/ANDA TAPE BACKUP OF ELECTRONIC COPY FOR DIMS Literal NL
NDA/ANDA MEDICAL OFFICER PAPER COPY Literal NM
NDA/ANDA PHARMACOKINETICS PAPER COPY Literal NP
NDA/ANDA TAPE BACKUP OF ELECTRONIC COPY FOR EDR Literal NR
NDA/ANDA STATISTICS PAPER COPY Literal NS
NDA/ANDA TEMPORARY JACKET Literal NT
NDA/ANDA VIDEO Literal NV
NDA/ANDA MICROBIOLOGIST PAPER COPY Literal NW
NDA/ANDA ORIGINAL ELECTRONIC COPY Literal NX
NDA/ANDA DUPLICATE ELECTRONIC COPY Literal NZ

 

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