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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020601
Company: J AND J CONSUMER INC

Products on NDA 020601

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHILDREN'S MOTRIN	IBUPROFEN	50MG	TABLET, CHEWABLE;ORAL	Discontinued	None	Yes	No
JUNIOR STRENGTH MOTRIN	IBUPROFEN	100MG	TABLET, CHEWABLE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020601

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/15/1996	ORIG-1	Approval	Type 8 - Partial Rx to OTC Switch	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
10/02/2018	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020601Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020601Orig1s021ltr.pdf
05/15/2017	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020601Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020601Orig1s020ltr.pdf
10/18/2010	SUPPL-18	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020601s018ltr.pdf
04/28/2009	SUPPL-17	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020601s017ltr.pdf
05/10/2006	SUPPL-14	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020601s014ltr.pdf
02/27/2006	SUPPL-13	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020601s013ltr.pdf
08/05/2002	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
05/02/2001	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
12/29/1999	SUPPL-5	Labeling		Label is not available on this site.
12/29/1999	SUPPL-4	Manufacturing (CMC)-Formulation		Label is not available on this site.
12/18/1998	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
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 is not available on this site.

Labels for NDA 020601

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/02/2018	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020601Orig1s021lbl.pdf
05/15/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020601Orig1s020lbl.pdf
09/13/1999	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf

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