Others titles
- FDA Drug Safety Labeling Changes
- FDA Drug Labeling Changes
Keywords
- SLC Changes
- FDA SLC
- Drug Labeling Changes
- FDA Drug Safety Labeling
- Safety Labeling Changes
- FDA Safety Labeling Changes
- SLC Program
Drug Safety Labeling Changes
The Drug Safety Labeling Changes (SLC) database provides approved safety labeling changes by the Center for Drug Evaluation and Research (CDER) from January 2021 forward.
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Description
As of September 1, 2016, the safety labeling changes (SLC) program will be managed by the Center for Drug Evaluation and Research’s (CDER’s) Office of Communications (OCOMM). OCOMM has established a new “Drug Safety Labeling Changes (SLC)” database that provides these data to the public.
These enhancements will allow health information technology vendors to more efficiently gather, organize and distribute information related to drug safety label changes. Providing drug safety labeling changes to healthcare vendors as quickly and efficiently as possible facilitates having the data further integrated into systems frequently accessed by health care providers.
Ultimately, the FDA expects that prompt access to these vital safety data by healthcare providers and consumers will better promote patient health.
About this Dataset
Data Info
Date Created | 2016-09-01 |
---|---|
Last Modified | 2022-10-01 |
Version | 2022-10-01 |
Update Frequency |
Irregular |
Temporal Coverage |
2019-01-01 to 2022-10-01 |
Spatial Coverage |
United States |
Source | John Snow Labs; U.S. Food and Drug Administration (FDA); |
Source License URL | |
Source License Requirements |
N/A |
Source Citation |
N/A |
Keywords | SLC Changes, FDA SLC, Drug Labeling Changes, FDA Drug Safety Labeling, Safety Labeling Changes, FDA Safety Labeling Changes, SLC Program |
Other Titles | FDA Drug Safety Labeling Changes, FDA Drug Labeling Changes |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Drug_Name | Drug name | string | required : 1 |
Active_Ingredient | Drug active ingredient | string | - |
Application_Number | Drug safety labeling Changes application number | integer | level : Nominalrequired : 1 |
Application_Type | Application type could be New Drug Application (NDA) or Biologics License Application (BLA) | string | enum : Array ( [0] => NDA [1] => BLA ) required : 1 |
Supplement_Date | Supplement date | date | required : 1 |
Database_Updated | Database update date | date | required : 1 |
Link | Product safety labeling changes FDA link | string | required : 1 |
Data Preview
Drug Name | Active Ingredient | Application Number | Application Type | Supplement Date | Database Updated | Link |
ABILIFY | ARIPIPRAZOLE | 21436 | NDA | 2020-02-05 | 2022-03-04 | https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=38 |
ABILIFY | ARIPIPRAZOLE | 21713 | NDA | 2020-02-05 | 2022-03-03 | https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=39 |
ABILIFY | ARIPIPRAZOLE | 21729 | NDA | 2020-02-05 | 2020-02-07 | https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=40 |
ABILIFY | ARIPIPRAZOLE | 21866 | NDA | 2020-02-05 | 2020-02-07 | https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=41 |
ABILIFY MAINTENA KIT | ARIPIPRAZOLE | 202971 | NDA | 2020-02-05 | 2020-02-07 | https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=24 |
ABILIFY MYCITE KIT | ARIPIPRAZOLE | 207202 | NDA | 2020-12-19 | 2020-12-30 | https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2193 |
ABRAXANE | PACLITAXEL | 21660 | NDA | 2020-08-25 | 2022-05-12 | https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1655 |
ABRILADA | ADALIMUMAB-AFZB | 761118 | BLA | 2022-07-29 | 2022-08-02 | https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2650 |
ABSORICA | ISOTRETINOIN | 21951 | NDA | 2019-11-07 | 2019-11-14 | https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1555 |
ABSTRAL | FENTANYL CITRATE | 22510 | NDA | 2019-10-07 | 2019-10-14 | https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=768 |