Drug Safety Labeling Changes

$79 / 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 health care 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

2017-10-03

Version

2017-10-03

Update Frequency

Irregular

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs => U.S. Food and Drug Administration (FDA)

Source License URL

John Snow Labs Standard License

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 numberintegerrequired : 1 level : Nominal
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
ALLIORLISTAT21887NDA2017-05-152017-05-18https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=220
DORALQUAZEPAM18708NDA2016-12-162016-12-21https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=606
LANOXINDIGOXIN9330NDA2016-12-012016-12-13https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=576
ONFICLOBAZAM202067NDA2016-12-162016-12-21https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=600
ONFICLOBAZAM203993NDA2016-12-162016-12-21https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=601
DIGOXINDIGOXIN21648NDA2016-12-012016-12-13https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=575
LANOXINDIGOXIN20405NDA2016-12-012016-12-13https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=578
MOBICMELOXICAM21530NDA2016-05-092016-08-08https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=192
MOBICMELOXICAM20938NDA2016-05-092016-08-08https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=193
VALIUMDIAZEPAM13263NDA2016-12-162016-12-21https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=607