Drugs@FDA: FDA Approved Drug Products

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

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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