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): 019833
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN’S ADVIL | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Discontinued |
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 |
|---|---|---|---|---|---|---|---|
| 09/19/1989 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/08/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19-833S011.pdf |
|
| 10/24/1994 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/27/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1994 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/1994 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
منبع : www.accessdata.fda.gov
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