Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020944
Company: HALEON US HOLDINGS

Products on NDA 020944

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHILDREN'S ADVIL	IBUPROFEN	50MG	TABLET, CHEWABLE;ORAL	Over-the-counter	None	No	No
JUNIOR STRENGTH ADVIL	IBUPROFEN	100MG	TABLET, CHEWABLE;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020944

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/26/2017	SUPPL-13	Labeling-Container/Carton Labels		Label is not available on this site.
03/27/2017	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020944Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020944Orig1s011ltr.pdf
02/13/2014	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/19/2009	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020944s008ltr.pdf
06/11/2008	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020944s006ltr.pdf
04/04/2006	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020944s005ltr.pdf
12/20/2004	SUPPL-3	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20944s002,003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020944Orig1s002_s003.pdf
12/20/2004	SUPPL-2	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20944s002,003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020944Orig1s002_s003.pdf

Labels for NDA 020944

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2017	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020944Orig1s011lbl.pdf
12/18/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil_prntlbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

CHILDREN'S ADVIL

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, CHEWABLE;ORAL; 50MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CHILDREN'S ADVIL	IBUPROFEN	50MG	TABLET, CHEWABLE;ORAL	Over-the-counter	No	020944	HALEON US HOLDINGS

JUNIOR STRENGTH ADVIL

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, CHEWABLE;ORAL; 100MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
IBUPROFEN	IBUPROFEN	100MG	TABLET, CHEWABLE;ORAL	Over-the-counter	No	076359	PERRIGO
JUNIOR STRENGTH ADVIL	IBUPROFEN	100MG	TABLET, CHEWABLE;ORAL	Over-the-counter	No	020944	HALEON US HOLDINGS