Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021374
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADVIL COLD AND SINUS IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE;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
05/30/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21374lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21374ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-374_Ibuprofen.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/24/2017 SUPPL-11 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021374Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021374Orig1s011ltr.pdf
03/14/2011 SUPPL-9 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021374s009ltr.pdf
05/19/2009 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021374s008ltr.pdf
06/23/2008 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021374s007ltr.pdf
12/07/2005 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021374s005ltr.pdf
04/17/2006 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021374s004ltr.pdf
10/17/2003 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21374SLR001_Advil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21374SLR001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/24/2017 SUPPL-11 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021374Orig1s011lbl.pdf
10/17/2003 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21374SLR001_Advil_lbl.pdf
05/30/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21374lbl.pdf

ADVIL COLD AND SINUS

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

CAPSULE;ORAL; EQ 200MG FREE ACID AND POTASSIUM SALT;30MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL COLD AND SINUS IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE EQ 200MG FREE ACID AND POTASSIUM SALT;30MG CAPSULE;ORAL Over-the-counter Yes 021374 PFIZER

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