Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021128
Company: J AND J CONSUMER INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S MOTRIN COLD IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100MG/5ML;15MG/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
08/01/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-128_ChildrensMotrin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/03/2017 SUPPL-10 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021228Orig1s010lbl.pdf
04/29/2009 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021128s009ltr.pdf
12/21/2005 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021128s007ltr.pdf
04/20/2005 SUPPL-6 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021128s006ltr.pdf
12/19/2003 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20516slr012,21128slr003ltr.pdf
05/02/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/03/2017 SUPPL-10 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021228Orig1s010lbl.pdf

CHILDREN'S MOTRIN COLD

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;15MG/5ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S ADVIL COLD IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100MG/5ML;15MG/5ML SUSPENSION;ORAL Over-the-counter No 021373 PFIZER
CHILDREN'S MOTRIN COLD IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100MG/5ML;15MG/5ML SUSPENSION;ORAL Over-the-counter Yes 021128 J AND J CONSUMER INC
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100MG/5ML;15MG/5ML SUSPENSION;ORAL Over-the-counter No 076478 PERRIGO

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