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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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) |
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 |
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) |
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 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020204s40ltr.pdf |
|
| 03/15/2012 | SUPPL-39 | Labeling |
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 |
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 |
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 |
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 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020204s035ltr.pdf |
|
| 04/15/2009 | SUPPL-32 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020204s032ltr.pdf |
|
| 11/24/2008 | SUPPL-31 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020204s031ltr.pdf |
|
| 01/06/2006 | SUPPL-23 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020204s023ltr.pdf |
|
| 05/04/2005 | SUPPL-21 | Labeling |
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 |
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) |
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 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20204s8ltr.pdf |
|
| 03/06/2001 | SUPPL-7 | Labeling |
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 |
نظرات کاربران