Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201803
Company: PFIZER CONS HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADVIL IBUPROFEN SODIUM EQ 200MG BASE TABLET;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
06/12/2012 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201803Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201803s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201803_advil_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201803Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/22/2017 SUPPL-9 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201803Orig1s009ltr.pdf
06/12/2017 SUPPL-8 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201803Orig1s008ltr.pdf
06/03/2016 SUPPL-7 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201803Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201803Orig1s007ltr.pdf
11/05/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/03/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/15/2013 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/22/2017 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s009lbl.pdf
06/12/2017 SUPPL-8 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s008lbl.pdf
06/03/2016 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201803Orig1s007lbl.pdf
06/12/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201803Orig1s000lbl.pdf

ADVIL

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

TABLET;ORAL; EQ 200MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL IBUPROFEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter Yes 201803 PFIZER CONS HLTHCARE
IBUPROFEN SODIUM IBUPROFEN SODIUM EQ 200MG BASE TABLET;ORAL Over-the-counter No 206581 PERRIGO R AND D

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