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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020603
Company: KENVUE BRANDS

Products on NDA 020603

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHILDREN'S MOTRIN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020603

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/1996	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/16/2017	SUPPL-22	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020603Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020603Orig1s022ltr.pdf
08/29/2016	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020603Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020603Orig1s021ltr.pdf
12/04/2015	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
07/15/2010	SUPPL-14	Labeling-Medication Guide	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020603s014ltr.pdf
04/29/2009	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020603s013ltr.pdf
02/27/2006	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020603s011ltr.pdf
01/16/2002	SUPPL-5	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20603s5lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20603s5ltr.pdf
05/03/2001	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
04/15/1999	SUPPL-3	Efficacy-New Patient Population	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S3_InfantsMotrin.pdf
09/13/1999	SUPPL-2	Labeling	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603s002_Ibuprofen.cfm
06/12/1998	SUPPL-1	Labeling	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603S001_Ibuprofen_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603S001_Ibuprofen_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603s001_Ibuprofen.cfm

Labels for NDA 020603

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/16/2017	SUPPL-22	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020603Orig1s022lbl.pdf
03/16/2017	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020603Orig1s022lbl.pdf
08/29/2016	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020603Orig1s021lbl.pdf
01/16/2002	SUPPL-5	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20603s5lbl.pdf
09/13/1999	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf
06/12/1998	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603S001_Ibuprofen_prntlbl.pdf

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

CHILDREN'S MOTRIN

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

SUSPENSION/DROPS;ORAL; 40MG/ML

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CHILDREN'S MOTRIN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS;ORAL	Over-the-counter	Yes	020603	KENVUE BRANDS
IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS;ORAL	Over-the-counter	No	210755	GUARDIAN DRUG
IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS;ORAL	Over-the-counter	No	075217	L PERRIGO CO
IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS;ORAL	Over-the-counter	No	217261	TARO
IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS;ORAL	Over-the-counter	No	079058	TRIS PHARMA INC

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