Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020589
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S ADVIL IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter None No No
CHILDREN'S ADVIL-FLAVORED IBUPROFEN 100MG/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
06/27/1996 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch 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
08/30/2018 SUPPL-37 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020589s037lbl.pdf
06/21/2017 SUPPL-35 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020589Orig1s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020589Orig1s035ltr.pdf
03/23/2017 SUPPL-34 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20589Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/20589Orig1s034ltr.pdf
07/28/2016 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/12/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/07/2012 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/04/2012 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

12/20/2013 SUPPL-29 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020589Orig1s029lbl_edt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020589Orig1s029ltr.pdf
09/02/2010 SUPPL-26 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020589s026ltr.pdf
05/19/2009 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020589s024ltr.pdf
06/11/2008 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020589s023ltr.pdf
12/07/2005 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020589s019ltr.pdf
03/18/2005 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20589s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20589s017ltr.pdf
11/14/2002 SUPPL-15 Labeling

Label is not available on this site.

08/02/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/2001 SUPPL-13 Manufacturing (CMC)-Formulation Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20589s13lbl.pdf
09/17/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/2000 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/30/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/2000 SUPPL-9 Labeling

Label is not available on this site.

10/17/1999 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/14/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/05/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/07/1997 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/30/2018 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020589s037lbl.pdf
06/21/2017 SUPPL-35 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020589Orig1s035lbl.pdf
03/23/2017 SUPPL-34 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20589Orig1s034lbl.pdf
12/20/2013 SUPPL-29 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020589Orig1s029lbl_edt.pdf
03/18/2005 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20589s017lbl.pdf
08/02/2001 SUPPL-13 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20589s13lbl.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.

SUSPENSION;ORAL; 100MG/5ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S ADVIL IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 020589 PFIZER
CHILDREN'S ADVIL-FLAVORED IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 020589 PFIZER
CHILDREN'S IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 074937 PERRIGO
CHILDREN'S MOTRIN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter Yes 020516 J AND J CONSUMER INC
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 210602 APTAPHARMA INC
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 200457 ARISE
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 209179 AUROBINDO PHARMA LTD
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 074916 P AND L
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 209207 TARO

CHILDREN'S ADVIL-FLAVORED

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
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S ADVIL IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 020589 PFIZER
CHILDREN'S ADVIL-FLAVORED IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 020589 PFIZER
CHILDREN'S IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 074937 PERRIGO
CHILDREN'S MOTRIN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter Yes 020516 J AND J CONSUMER INC
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 210602 APTAPHARMA INC
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 200457 ARISE
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 209179 AUROBINDO PHARMA LTD
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 074916 P AND L
IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION;ORAL Over-the-counter No 209207 TARO

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English