Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021373
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S ADVIL COLD IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100MG/5ML;15MG/5ML SUSPENSION;ORAL Over-the-counter None No 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
04/18/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21373lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21373ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-373_Ibuprofen%20Childrens%20Advil.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/24/2017 SUPPL-13 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021373Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021373Orig1s013ltr.pdf
12/07/2012 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/24/2010 SUPPL-11 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021373s011ltr.pdf
05/19/2009 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021373s009ltr.pdf
12/03/2008 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021373s008ltr.pdf
04/04/2006 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021373s005ltr.pdf
01/12/2005 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21373s003ltr.pdf
03/25/2003 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21373slr001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/24/2017 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021373Orig1s013lbl.pdf
04/18/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21373lbl.pdf

CHILDREN'S ADVIL 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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