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ALEVE از شرکت BAYER

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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
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ALEVE از شرکت BAYER

New Drug Application (NDA): 020204

Company: BAYER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALEVE NAPROXEN SODIUM 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
01/11/1994 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/01/2021 SUPPL-81 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020204Orig1s081Lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020204Orig1s081ltr.pdf

12/31/2020 SUPPL-80 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s080lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020204Orig1s080ltr.pdf

12/31/2020 SUPPL-79 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s079lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020204Orig1s079ltr.pdf

12/31/2020 SUPPL-78 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s078lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020204Orig1s078ltr.pdf

12/31/2020 SUPPL-77 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s077lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020204Orig1s077ltr.pdf

10/28/2020 SUPPL-76 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s076lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020204orig1s076ltr.pdf

05/08/2020 SUPPL-72 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s072Lbledt.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020204Orig1s072ltr.pdf

04/23/2020 SUPPL-71 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s071lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020204Orig1s071ltr.pdf

03/02/2020 SUPPL-70 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s070lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020204Orig1s070ltr.pdf

08/07/2019 SUPPL-68 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020204Orig1s068lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020204Orig1s068ltr.pdf

07/23/2019 SUPPL-67 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020204Orig1s067lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020204Orig1s067ltr.pdf

07/02/2019 SUPPL-66 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020204Orig1s066lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020204Orig1s066ltr.pdf

05/13/2019 SUPPL-65 Labeling-Container/Carton Labels

Label is not available on this site.

05/13/2019 SUPPL-64 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020204Orig1s064lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020204Orig1s064ltr.pdf

05/13/2019 SUPPL-63 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020204Orig1s063ltr.pdf

01/03/2019 SUPPL-62 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020204Orig1s062lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020204Orig1s062ltr.pdf

01/28/2019 SUPPL-61 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020204Orig1s061lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020204Orig1s061ltr.pdf

09/21/2018 SUPPL-59 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s059lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020204Orig1s059ltr.pdf

08/28/2018 SUPPL-58 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204s058lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020204Orig1s058ltr.pdf

07/25/2018 SUPPL-57 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s057Lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020204Orig1s057Ltr.pdf

06/11/2018 SUPPL-56 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s056lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020204Orig1s056ltr.pdf

06/08/2018 SUPPL-55 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s055lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020204Orig1s055ltr.pdf

03/29/2018 SUPPL-54 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s054lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020204Orig1s054ltr.pdf

03/27/2018 SUPPL-53 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s053lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020204Orig1s053ltr.pdf

09/14/2017 SUPPL-52 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020204Orig1s052lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020204Orig1s052ltr.pdf

08/22/2017 SUPPL-51 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020204Orig1s051lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020204Orig1s051ltr.pdf

07/28/2016 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

02/25/2016 SUPPL-48 Manufacturing (CMC)

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020204Orig1s048Lbl.pdf

02/04/2015 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

04/18/2013 SUPPL-44 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020204Orig1s044lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020204Orig1s044ltr.pdf

01/07/2013 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

01/03/2013 SUPPL-42 Manufacturing (CMC)

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020204Orig1s042ltr.pdf

11/13/2012 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

03/16/2012 SUPPL-40 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020204s40ltr.pdf

03/15/2012 SUPPL-39 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020204Orig1s039ltr.pdf

02/07/2013 SUPPL-38 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020204Orig1s038lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020204Orig1s038ltr.pdf

04/08/2011 SUPPL-37 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020204s037ltr.pdf

02/18/2011 SUPPL-36 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020204s036ltr.pdf

11/03/2010 SUPPL-35 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020204s035ltr.pdf

04/15/2009 SUPPL-32 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020204s032ltr.pdf

11/24/2008 SUPPL-31 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020204s031ltr.pdf

01/06/2006 SUPPL-23 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020204s023ltr.pdf

05/04/2005 SUPPL-21 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020204s021lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020204s021ltr.pdf

03/22/2004 SUPPL-19 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20204slr019ltr.pdf

08/30/2002 SUPPL-16 Manufacturing (CMC)

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20204scm016ltr.pdf

12/21/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/03/2001 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/07/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/11/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/23/2000 SUPPL-10 Labeling

Label is not available on this site.

03/19/2002 SUPPL-8 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20204s8ltr.pdf

03/06/2001 SUPPL-7 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20204S7LTR.PDF

11/20/1998 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/16/1998 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/01/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/10/1995 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/12/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/01/2021 SUPPL-81

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020204Orig1s081Lbl.pdf
12/31/2020 SUPPL-80

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s080lbl.pdf
12/31/2020 SUPPL-79

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s079lbl.pdf
12/31/2020 SUPPL-78

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s078lbl.pdf
12/31/2020 SUPPL-77

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s077lbl.pdf
10/28/2020 SUPPL-76

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s076lbl.pdf
05/08/2020 SUPPL-72

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s072Lbledt.pdf
04/23/2020 SUPPL-71

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s071lbl.pdf
03/02/2020 SUPPL-70

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020204Orig1s070lbl.pdf
08/07/2019 SUPPL-68

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020204Orig1s068lbl.pdf
07/23/2019 SUPPL-67

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020204Orig1s067lbl.pdf
07/02/2019 SUPPL-66

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020204Orig1s066lbl.pdf
05/13/2019 SUPPL-64

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020204Orig1s064lbl.pdf
01/28/2019 SUPPL-61

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020204Orig1s061lbl.pdf
01/03/2019 SUPPL-62

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020204Orig1s062lbl.pdf
09/21/2018 SUPPL-59

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s059lbl.pdf
08/28/2018 SUPPL-58

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204s058lbl.pdf
07/25/2018 SUPPL-57

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s057Lbl.pdf
06/11/2018 SUPPL-56

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s056lbl.pdf
06/08/2018 SUPPL-55

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s055lbl.pdf
03/29/2018 SUPPL-54

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s054lbl.pdf
03/27/2018 SUPPL-53

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020204Orig1s053lbl.pdf
09/14/2017 SUPPL-52

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020204Orig1s052lbl.pdf
08/22/2017 SUPPL-51

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020204Orig1s051lbl.pdf
02/25/2016 SUPPL-48

Manufacturing (CMC)

Label (PDF)

This supplement type does not usually require new labeling.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020204Orig1s048Lbl.pdf
04/18/2013 SUPPL-44

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020204Orig1s044lbl.pdf
02/07/2013 SUPPL-38

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020204Orig1s038lbl.pdf
05/04/2005 SUPPL-21

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020204s021lbl.pdf

ALEVE

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

TABLET;ORAL; 220MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALEVE NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter Yes 020204 BAYER
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 079096 AMNEAL PHARMS NY
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 205497 AUROBINDO PHARMA LTD
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 074635 CONTRACT PHARMACAL
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 075168 DR REDDYS LABS INC
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 091353 GRANULES INDIA
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 204872 LNK INTL INC
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 090545 MARKSANS PHARMA
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 207612 NOVELGENIX THERAPS
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 074661 PERRIGO
NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET;ORAL Over-the-counter No 091183 SUN PHARM INDS LTD
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