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DATA STANDARDS MANUAL |
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DATA STANDARDS MANUAL |
FDA Data Element Number. None.
CDER Data Element Number. C-DRG-00921
Version Number. 001
Data Element Name. Global Supplement Status
Description. This standard provides for all global supplement status codes. A global supplement is a group of supplements covering the identical change, and from a single sponsor.
Source. Office of Generic Drug Products
Relationship.
FDA Specifications. None.
CDER Specifications. Global Supplement Status shall consist of an alphabetic term which has a maximum length restricted to 100 characters, with the comma and hyphen being the only punctuation permissible. Codes representing each Global Supplement Status shall consist of digits.
FDA Approved Date. None.
CDER Approved Date. September 6, 2000
FDA Revised Date.
CDER Revised Date.
Data Values.
| DEFINITION | NAME | FDA CODE |
|---|---|---|
| GLOBAL GRANTED | Literal | 1 |
| GLOBAL TENTATIVE | Literal | 2 |
| GLOBAL DENIED | Literal | 3 |