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 ALLERGY SINUS از شرکت GLAXOSMITHKLINE
New Drug Application (NDA): 021587
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN’S ADVIL ALLERGY SINUS | CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1MG/5ML;100MG/5ML;15MG/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 02/24/2004 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21587_childrens_advil.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2017 | SUPPL-6 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021587Orig1s006lbl.pdf |
||
| 04/04/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021587s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/24/2017 | SUPPL-6 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021587Orig1s006lbl.pdf | |
| 02/24/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21587_childrens_advil.pdf |
CHILDREN’S ADVIL ALLERGY SINUS
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUSPENSION;ORAL; 1MG/5ML;100MG/5ML;15MG/5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN’S ADVIL ALLERGY SINUS | CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 1MG/5ML;100MG/5ML;15MG/5ML | SUSPENSION;ORAL | Over-the-counter | Yes | 021587 | GLAXOSMITHKLINE |
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