Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205352
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALEVE PM DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM 25MG;220MG 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
01/17/2014 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205352Orig1s000lbl_corrected.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205352Orig1s000ltr_corrected.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205352Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205352Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/12/2017 SUPPL-9 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205352Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205352Orig1s009ltr.pdf
12/23/2015 SUPPL-7 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s007ltr.pdf
10/28/2015 SUPPL-6 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s006ltr.pdf
08/14/2015 SUPPL-5 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s005ltr.pdf
07/15/2015 SUPPL-4 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s004ltr.pdf
02/25/2015 SUPPL-3 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s003ltr.pdf
11/20/2014 SUPPL-2 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205352Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205352Orig1s002ltr.pdf
08/28/2014 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205352Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205352Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/12/2017 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205352Orig1s009lbl.pdf
10/28/2015 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s006lbl.pdf
08/14/2015 SUPPL-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s005lbl.pdf
07/15/2015 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s004lbl.pdf
02/25/2015 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s003lbl.pdf
11/20/2014 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205352Orig1s002lbl.pdf
08/28/2014 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205352Orig1s001lbl.pdf
01/17/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205352Orig1s000lbl_corrected.pdf

ALEVE 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; 25MG;220MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALEVE PM DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM 25MG;220MG TABLET;ORAL Over-the-counter Yes 205352 BAYER HLTHCARE

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