Drug Safety Labeling Changes

$179 / year

The Drug Safety Labeling Changes (SLC) database provides approved safety labeling changes by the Center for Drug Evaluation and Research (CDER) from January 2016 forward.

Complexity

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.

Date Created

2016-09-01

Last Modified

2020-04-23

Version

2020-04-23

Update Frequency

Irregular

Temporal Coverage

2019-01-01 to 2020-04-23

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

NameDescriptionTypeConstraints
Drug_NameDrug namestringrequired : 1
Active_IngredientDrug active ingredientstring-
Application_NumberDrug safety labeling Changes application numberintegerlevel : Nominal required : 1
Application_TypeApplication type could be New Drug Application (NDA) or Biologics License Application (BLA)stringenum : Array required : 1
Supplement_DateSupplement datedaterequired : 1
Database_UpdatedDatabase update datedaterequired : 1
LinkProduct safety labeling changes FDA linkstringrequired : 1
Drug NameActive IngredientApplication NumberApplication TypeSupplement DateDatabase UpdatedLink
ABILIFYARIPIPRAZOLE21436NDA2020-02-052020-02-07https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=38
ABILIFYARIPIPRAZOLE21713NDA2020-02-052020-02-07https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=39
ABILIFYARIPIPRAZOLE21729NDA2020-02-052020-02-07https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=40
ABILIFYARIPIPRAZOLE21866NDA2020-02-052020-02-07https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=41
ABILIFY MAINTENA KITARIPIPRAZOLE202971NDA2020-02-052020-02-07https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=24
ABILIFY MYCITE KITARIPIPRAZOLE207202NDA2020-02-052020-02-07https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2193
ABRAXANEPACLITAXEL21660NDA2019-12-062019-12-09https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1655
ABSORICAISOTRETINOIN21951NDA2019-11-072019-11-14https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1555
ABSTRALFENTANYL CITRATE22510NDA2019-10-072019-10-14https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=768
ACTEMRATOCILIZUMAB125276BLA2019-06-112019-06-13https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=440