Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020603
Company: J AND J CONSUMER INC
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
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-Package Insert, Labeling-Container/Carton Labels 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/16/2017 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020603Orig1s022lbl.pdf
03/16/2017 SUPPL-22 Labeling-Container/Carton Labels 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

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 J AND J CONSUMER INC
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 079058 TRIS PHARMA INC

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