SPL Coating

FDA Data Element Number.  Pending.

CDER Data Element Number.  C-DRG-0925

Data Element Name.  SPLCOATING

Version Number:  1.0

Description.  A characteristic of an oral solid dosage form of a medicinal product, indicating whether it has one or more coatings, such as sugar coating, film coating, or enteric coating.  Only coatings to the external surface or the dosage form should be considered (for example, coatings to individual pellets or granules inside a capsule or tablet are excluded from consideration).

Constraints: The Observation.value must be a Boolean (BL) with true for the presence or false for the absence of one or more coatings on a solid dosage form.

Source.  SPL


FDA Specifications. 

CDER Specifications.  No further specifications.

FDA Approved Date.  25-MAY-2005

CDER Approved Date.  25-MAY-2005

FDA Revised Date. 

CDER Revised Date.

Data Values.  See constraints.

Page Last Updated: 12/10/2014
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