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
CHILDREN’S ADVIL از شرکت GLAXOSMITHKLINE
New Drug Application (NDA): 020944
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN’S ADVIL | IBUPROFEN | 50MG | TABLET, CHEWABLE;ORAL | Over-the-counter |
None |
No | No |
| JUNIOR STRENGTH ADVIL | IBUPROFEN | 100MG | TABLET, CHEWABLE;ORAL | Over-the-counter |
None |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/18/1998 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil_prntlbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/26/2017 | SUPPL-13 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/27/2017 | SUPPL-11 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020944Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020944Orig1s011ltr.pdf |
||
| 02/13/2014 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020944s008ltr.pdf |
|
| 06/11/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020944s006ltr.pdf |
|
| 04/04/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020944s005ltr.pdf |
|
| 12/20/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20944s002,003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020944Orig1s002_s003.pdf |
|
| 12/20/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20944s002,003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020944Orig1s002_s003.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/27/2017 | SUPPL-11 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020944Orig1s011lbl.pdf | |
| 12/18/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil_prntlbl.pdf |
CHILDREN’S ADVIL
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, CHEWABLE;ORAL; 50MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN’S ADVIL | IBUPROFEN | 50MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 020944 | GLAXOSMITHKLINE |
JUNIOR STRENGTH ADVIL
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, CHEWABLE;ORAL; 100MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | 100MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 076359 | PERRIGO |
| JUNIOR STRENGTH ADVIL | IBUPROFEN | 100MG | TABLET, CHEWABLE;ORAL | Over-the-counter | No | 020944 | GLAXOSMITHKLINE |
نظرات کاربران