Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021394
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADVIL PM DIPHENHYDRAMINE CITRATE; IBUPROFEN 38MG;200MG 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
12/21/2005 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021393,021394lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021393,021394ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021393,021394_AdvilTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/21/2017 SUPPL-23 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021394Orig1s023ltr.pdf
03/30/2017 SUPPL-21 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021394Orig1s021ltr.pdf
03/15/2016 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/05/2015 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/07/2015 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/01/2010 SUPPL-15 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021394s015ltr.pdf
04/25/2011 SUPPL-14 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021394s014ltr.pdf
05/19/2009 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021394s012ltr.pdf
06/11/2008 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021394s010ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/21/2017 SUPPL-23 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s023lbl.pdf
03/30/2017 SUPPL-21 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s021lbl.pdf
12/21/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021393,021394lbl.pdf

ADVIL PM

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

TABLET;ORAL; 38MG;200MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL PM DIPHENHYDRAMINE CITRATE; IBUPROFEN 38MG;200MG TABLET;ORAL Over-the-counter Yes 021394 PFIZER
IBUPROFEN AND DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE CITRATE; IBUPROFEN 38MG;200MG TABLET;ORAL Over-the-counter No 090619 DR REDDYS LABS LTD
IBUPROFEN AND DIPHENHYDRAMINE CITRATE DIPHENHYDRAMINE CITRATE; IBUPROFEN 38MG;200MG TABLET;ORAL Over-the-counter No 079113 PERRIGO R AND D

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