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 CONGESTION RELIEF از شرکت GLAXOSMITHKLINE
New Drug Application (NDA): 022565
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADVIL CONGESTION RELIEF | IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 200MG;10MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/27/2010 | ORIG-1 | Approval |
Type 4 – New Combination |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022565s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/30/2020 | SUPPL-6 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022565Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022565Orig1s006ltr.pdf |
||
| 07/09/2019 | SUPPL-5 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s007; 022565Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022113Orig1s007;%20022565Orig1s005ltr.pdf |
||
| 03/24/2017 | SUPPL-3 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022565Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022565Orig1s003ltr.pdf |
||
| 03/30/2015 | SUPPL-2 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022565Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022565Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/30/2020 | SUPPL-6 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022565Orig1s006lbl.pdf | |
| 07/09/2019 | SUPPL-5 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022113Orig1s007; 022565Orig1s005lbl.pdf | |
| 03/24/2017 | SUPPL-3 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022565Orig1s003lbl.pdf | |
| 03/30/2015 | SUPPL-2 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022565Orig1s002lbl.pdf |
ADVIL CONGESTION RELIEF
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 200MG;10MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ADVIL CONGESTION RELIEF | IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 200MG;10MG | TABLET;ORAL | Over-the-counter | Yes | 022565 | GLAXOSMITHKLINE |
| IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE | IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 200MG;10MG | TABLET;ORAL | Over-the-counter | No | 203200 | PERRIGO R AND D |
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