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- Bd69e53ab8fa3f9003863bf50b8be4aa4 NCIT_P378 "FDA" @default.
- Bd69e53ab8fa3f9003863bf50b8be4aa4 NCIT_P381 "eCTD" @default.
- Bd69e53ab8fa3f9003863bf50b8be4aa4 type Axiom @default.
- Bd69e53ab8fa3f9003863bf50b8be4aa4 annotatedProperty NCIT_P325 @default.
- Bd69e53ab8fa3f9003863bf50b8be4aa4 annotatedSource NCIT_C97023 @default.
- Bd69e53ab8fa3f9003863bf50b8be4aa4 annotatedTarget "For NDAs, ANDAs, and BLAs, this represents a request to modify an existing label that do not rise to the level of an efficacy supplement for purposes such as adding additional safety information, clarification, etc. Labeling supplements may only be submitted once the original-application has been approved/licensed." @default.