Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022565
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADVIL CONGESTION RELIEF IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG 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
05/27/2010 ORIG-1 Approval Type 4 - New Combination STANDARD Letter (PDF)
Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022565s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022565s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022565s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/24/2017 SUPPL-3 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022565Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022565Orig1s003ltr.pdf
03/30/2015 SUPPL-2 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022565Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022565Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/24/2017 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022565Orig1s003lbl.pdf
03/30/2015 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022565Orig1s002lbl.pdf

ADVIL CONGESTION RELIEF

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

TABLET;ORAL; 200MG;10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL CONGESTION RELIEF IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET;ORAL Over-the-counter Yes 022565 PFIZER
IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET;ORAL Over-the-counter No 203200 PERRIGO R AND D

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