CDER DATA STANDARDS MANUAL

FDA Data Element Number.

CDER Data Element Number. C-GEN-10208

Data Element Name. Application Number

Description. Application Number is the number associated with the primary category of official submission that is received by the Center.

Source. Various Oracle tables, including COMIS Reference Table.

Relationship. See Application Type.

FDA Specifications. None.

CDER Specifications. Application Number is represented by numeric text of six character in length, with leading zeros and without punctuation.

FDA Approved Date.

CDER Approved Date. March 14, 1995

FDA Revised Date.

CDER Revised Date.

Data Values. Literal.

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