CHILDREN’S MOTRIN از شرکت J AND J CONSUMER INC

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CHILDREN’S MOTRIN از شرکت J AND J CONSUMER INC

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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