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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021373
Company: HALEON US HOLDINGS

Products on NDA 021373

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHILDREN'S ADVIL COLD	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	100MG/5ML;15MG/5ML	SUSPENSION;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021373

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/18/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21373lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21373ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-373_Ibuprofen%20Childrens%20Advil.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/24/2017	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021373Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021373Orig1s013ltr.pdf
12/07/2012	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/24/2010	SUPPL-11	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021373s011ltr.pdf
05/19/2009	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021373s009ltr.pdf
12/03/2008	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021373s008ltr.pdf
04/04/2006	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021373s005ltr.pdf
01/12/2005	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21373s003ltr.pdf
03/25/2003	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21373slr001ltr.pdf

Labels for NDA 021373

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/24/2017	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021373Orig1s013lbl.pdf
04/18/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21373lbl.pdf

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

CHILDREN'S ADVIL COLD

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

SUSPENSION;ORAL; 100MG/5ML;15MG/5ML

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CHILDREN'S ADVIL COLD	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	100MG/5ML;15MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	021373	HALEON US HOLDINGS
CHILDREN'S MOTRIN COLD	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	100MG/5ML;15MG/5ML	SUSPENSION;ORAL	Over-the-counter	Yes	021128	J AND J CONSUMER INC

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