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
ADVIL از شرکت GLAXOSMITHKLINE
New Drug Application (NDA): 201803
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADVIL | IBUPROFEN SODIUM | EQ 200MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 06/12/2012 | ORIG-1 | Approval |
Type 2 – New Active Ingredient |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201803Orig1s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/31/2018 | SUPPL-12 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201803Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201803Orig1s012ltr.pdf |
||
| 04/12/2018 | SUPPL-11 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201803Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201803Orig1s011ltr.pdf |
||
| 08/22/2017 | SUPPL-9 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201803Orig1s009ltr.pdf |
||
| 06/12/2017 | SUPPL-8 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201803Orig1s008ltr.pdf |
||
| 06/03/2016 | SUPPL-7 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201803Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201803Orig1s007ltr.pdf |
||
| 11/05/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/2013 | 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 |
|---|---|---|---|---|---|
| 05/31/2018 | SUPPL-12 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201803Orig1s012lbl.pdf | |
| 04/12/2018 | SUPPL-11 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201803Orig1s011lbl.pdf | |
| 08/22/2017 | SUPPL-9 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s009lbl.pdf | |
| 06/12/2017 | SUPPL-8 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s008lbl.pdf | |
| 06/03/2016 | SUPPL-7 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201803Orig1s007lbl.pdf | |
| 06/12/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201803Orig1s000lbl.pdf |
ADVIL
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; EQ 200MG BASE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ADVIL | IBUPROFEN SODIUM | EQ 200MG BASE | TABLET;ORAL | Over-the-counter | Yes | 201803 | GLAXOSMITHKLINE |
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