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U.S. Department of Health and Human Services

Drugs

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Pediatric Exclusivity Study Drug List

FDA Data Element Number.

CDER Data Element Number. C-DRG-00911

Version Number. 001

Data Element Name. Pediatric Exclusivity Study Drug List

Description. Pediatric Exclusivity Study Drug List describes whether a drug is marketed, and if so, whether it already appears on the Pediatric Exclusivity List.

Source.

Relationship.

FDA Specifications.

CDER Specifications. Pediatric Exclusivity Study Drug List shall consist of an alphanumeric term which has a maximum length restricted to 240 characters, and a corresponding numeric code with a maximum length of 3 characters. (Reference table column_id = PED_EX_STUDY_DRUG_LIST).

FDA Approved Date.

CDER Approved Date. February 1, 2000

FDA Revised Date.

CDER Revised Date.

Data Values.

NAME DEFINITION FDA CODE
DRUG ALREADY MARKETED, ON THE LIST Literal 1
DRUG ALREADY MARKETED, NOT ON THE LIST Literal 2
DRUG NOT MARKETED Literal 3