Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020812
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INFANT'S ADVIL IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS;ORAL Over-the-counter None Yes Yes
PEDIATRIC ADVIL IBUPROFEN 100MG/2.5ML SUSPENSION/DROPS;ORAL Discontinued None Yes 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
01/30/1998 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/98/020812_PediatricTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/06/2017 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020812Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020812Orig1s024ltr.pdf
03/24/2017 SUPPL-23 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020812Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020812Orig1s023ltr.pdf
02/26/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

03/11/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

12/06/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/24/2013 SUPPL-19 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020812s019lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020812Orig1s019ltr.pdf
04/26/2011 SUPPL-17 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020812s017ltr.pdf
05/19/2009 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020812s015ltr.pdf
06/11/2008 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020812s014ltr.pdf
04/04/2006 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020812s012ltr.pdf
09/10/2004 SUPPL-11 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20812s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020812Orig1s011.pdf
06/28/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/2000 SUPPL-7 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020812Orig1s007.pdf
02/10/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/12/2000 SUPPL-3 Efficacy-New Patient Population Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020812s003lbl.pdf
05/19/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/19/1998 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/06/2017 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020812Orig1s024lbl.pdf
03/24/2017 SUPPL-23 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020812Orig1s023lbl.pdf
07/24/2013 SUPPL-19 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020812s019lbledt.pdf
01/12/2000 SUPPL-3 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020812s003lbl.pdf

INFANT'S ADVIL

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; 50MG/1.25ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
INFANT'S ADVIL IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS;ORAL Over-the-counter Yes 020812 PFIZER

PEDIATRIC ADVIL

There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.

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