ALEVE PM از شرکت BAYER HLTHCARE

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
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ALEVE PM از شرکت BAYER HLTHCARE

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
10/30/2020 SUPPL-15 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205352Orig1s015lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205352Orig1s015ltr.pdf

04/06/2020 SUPPL-14 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205352Orig1s014lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205352Orig1s014ltr.pdf

04/10/2019 SUPPL-13 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205352Orig1s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205352Orig1s013ltr.pdf

08/28/2018 SUPPL-11 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205352s011lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205352Orig1s011ltr.pdf

01/16/2018 SUPPL-10

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205352Orig1s010lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205352Orig1s010ltr.pdf

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
10/30/2020 SUPPL-15

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205352Orig1s015lbl.pdf
04/06/2020 SUPPL-14

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205352Orig1s014lbl.pdf
04/10/2019 SUPPL-13

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205352Orig1s013lbl.pdf
08/28/2018 SUPPL-11

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205352s011lbl.pdf
01/16/2018 SUPPL-10

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205352Orig1s010lbl.pdf
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
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM 25MG;220MG TABLET;ORAL Over-the-counter No 209726 AMNEAL PHARMS CO
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM 25MG;220MG TABLET;ORAL Over-the-counter No 211830 APOTEX
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM 25MG;220MG TABLET;ORAL Over-the-counter No 213663 GRANULES
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM 25MG;220MG TABLET;ORAL Over-the-counter No 208499 PERRIGO R AND D
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