Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020944
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S ADVIL IBUPROFEN 50MG TABLET, CHEWABLE;ORAL Over-the-counter None No No
JUNIOR STRENGTH ADVIL IBUPROFEN 100MG TABLET, CHEWABLE;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
12/18/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/26/2017 SUPPL-13 Labeling-Container/Carton Labels

Label is not available on this site.

03/27/2017 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020944Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020944Orig1s011ltr.pdf
02/13/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/19/2009 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020944s008ltr.pdf
06/11/2008 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020944s006ltr.pdf
04/04/2006 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020944s005ltr.pdf
12/20/2004 SUPPL-3 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20944s002,003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020944Orig1s002_s003.pdf
12/20/2004 SUPPL-2 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20944s002,003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020944Orig1s002_s003.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/27/2017 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020944Orig1s011lbl.pdf
12/18/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil_prntlbl.pdf

CHILDREN'S ADVIL

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, CHEWABLE;ORAL; 50MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S ADVIL IBUPROFEN 50MG TABLET, CHEWABLE;ORAL Over-the-counter No 020944 PFIZER

JUNIOR STRENGTH ADVIL

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, CHEWABLE;ORAL; 100MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
IBUPROFEN IBUPROFEN 100MG TABLET, CHEWABLE;ORAL Over-the-counter No 076359 PERRIGO
JUNIOR STRENGTH ADVIL IBUPROFEN 100MG TABLET, CHEWABLE;ORAL Over-the-counter No 020944 PFIZER

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