Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 020812
Company: HALEON US HOLDINGS

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INFANT'S ADVIL	IBUPROFEN	50MG/1.25ML	SUSPENSION/DROPS;ORAL	Over-the-counter	None	Yes	Yes
PEDIATRIC ADVIL	IBUPROFEN	100MG/2.5ML	SUSPENSION/DROPS;ORAL	Discontinued	None	Yes	No

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/06/2017	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020812Orig1s024lbl.pdf
03/24/2017	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020812Orig1s023lbl.pdf
07/24/2013	SUPPL-19	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020812s019lbledt.pdf
01/12/2000	SUPPL-3	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020812s003lbl.pdf