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 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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205352Orig1s000lbl_corrected.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 |
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 |
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 |
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 |
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 |
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 |
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) |
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 |
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 |
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 |
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 |
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 |
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 |
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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