Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021441
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADVIL ALLERGY SINUS CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 2MG;200MG;30MG 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
12/19/2002 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21441_Advil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-441_Advil%20Allergy-Sinus_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-441_Advil.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/24/2017 SUPPL-12 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021441Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021441Orig1s012ltr.pdf
08/31/2010 SUPPL-11 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021441s011ltr.pdf
05/19/2009 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021441s009ltr.pdf
06/23/2008 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021441s008ltr.pdf
02/27/2006 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021441s005ltr.pdf
07/09/2004 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21441slr001_advil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21441slr001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/24/2017 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021441Orig1s012lbl.pdf
07/09/2004 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21441slr001_advil_lbl.pdf
12/19/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21441_Advil_lbl.pdf

ADVIL ALLERGY SINUS

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

TABLET;ORAL; 2MG;200MG;30MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL ALLERGY SINUS CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 2MG;200MG;30MG TABLET;ORAL Over-the-counter Yes 021441 PFIZER

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