Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021393
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADVIL PM DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT 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
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
03/29/2017 SUPPL-14 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021393Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021393Orig1s014ltr.pdf
02/04/2013 SUPPL-12 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021393Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021393Orig1s012ltr.pdf
04/20/2011 SUPPL-7 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021393s007ltr.pdf
05/19/2009 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021393s006ltr.pdf
06/11/2008 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021393s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/29/2017 SUPPL-14 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021393Orig1s014lbl.pdf
02/04/2013 SUPPL-12 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021393Orig1s012lbl.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.

CAPSULE;ORAL; 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ADVIL PM DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter Yes 021393 PFIZER
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 090397 BIONPHARMA INC
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE;ORAL Over-the-counter No 200888 STRIDES PHARMA

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