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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020602
Company: J AND J CONSUMER INC

Products on NDA 020602

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JUNIOR STRENGTH MOTRIN	IBUPROFEN	100MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020602

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 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
05/15/2017	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020602Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020602Orig1s013ltr.pdf
10/13/2010	SUPPL-10	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020602s010ltr.pdf
04/27/2009	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020602s009ltr.pdf
02/27/2006	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020602s008ltr.pdf
05/02/2001	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
09/13/1999	SUPPL-3	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-2	Labeling		Label is not available on this site.
06/12/1998	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020602

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/15/2017	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020602Orig1s013lbl.pdf
09/13/1999	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf

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

JUNIOR STRENGTH MOTRIN

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

TABLET;ORAL; 100MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
JUNIOR STRENGTH ADVIL	IBUPROFEN	100MG	TABLET;ORAL	Over-the-counter	No	020267	HALEON US HOLDINGS
JUNIOR STRENGTH MOTRIN	IBUPROFEN	100MG	TABLET;ORAL	Over-the-counter	No	020602	J AND J CONSUMER INC

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