Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020516
Company: J AND J CONSUMER INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S MOTRIN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/16/1995 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
11/29/2018 SUPPL-36 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020516Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020516Orig1s036ltr.pdf
03/14/2017 SUPPL-35 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020516Orig1s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020516Orig1s035ltr.pdf
01/09/2017 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/16/2016 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020516Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020516Orig1s033ltr.pdf
06/17/2016 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/07/2015 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/16/2015 SUPPL-30 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020516Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020516Orig1s030ltr.pdf
12/11/2014 SUPPL-29 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020516Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020516Orig1s029ltr.pdf
11/19/2012 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

08/12/2012 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/06/2011 SUPPL-24 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020516s024ltr.pdf
10/19/2010 SUPPL-22 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020516s022ltr.pdf
04/29/2009 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020516s021ltr.pdf
06/22/2006 SUPPL-20 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020516s020LTR.pdf
12/07/2005 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020516s018ltr.pdf
02/07/2005 SUPPL-16 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20516s016ltr.pdf
12/19/2003 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20516slr012,21128slr003ltr.pdf
10/28/2003 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19012slr034,20516slr011ltr.pdf
05/02/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/2000 SUPPL-6 Labeling

Label is not available on this site.

09/13/1999 SUPPL-4 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
12/18/1998 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/04/1998 SUPPL-2 Labeling

Label is not available on this site.

03/31/1997 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
11/29/2018 SUPPL-36 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020516Orig1s036lbl.pdf
03/14/2017 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020516Orig1s035lbl.pdf
03/14/2017 SUPPL-35 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020516Orig1s035lbl.pdf
06/16/2016 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020516Orig1s033lbl.pdf
04/16/2015 SUPPL-30 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020516Orig1s030lbl.pdf
12/11/2014 SUPPL-29 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020516Orig1s029lbl.pdf
09/13/1999 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf

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;ORAL; 100MG/5ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S ADVIL IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 020589 PFIZER
CHILDREN'S ADVIL-FLAVORED IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 020589 PFIZER
CHILDREN'S IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 074937 PERRIGO
CHILDREN'S MOTRIN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter Yes 020516 J AND J CONSUMER INC
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 210602 APTAPHARMA INC
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 200457 ARISE
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 209179 AUROBINDO PHARMA LTD
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 074916 P AND L
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 209207 TARO

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