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 COLD از شرکت GLAXOSMITHKLINE
New Drug Application (NDA): 021373
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN’S ADVIL COLD | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 100MG/5ML;15MG/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 04/18/2002 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21373lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2017 | SUPPL-13 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021373Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021373Orig1s013ltr.pdf |
||
| 12/07/2012 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/2010 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021373s011ltr.pdf |
|
| 05/19/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021373s009ltr.pdf |
|
| 12/03/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021373s008ltr.pdf |
|
| 04/04/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021373s005ltr.pdf |
|
| 01/12/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21373s003ltr.pdf |
|
| 03/25/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21373slr001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/24/2017 | SUPPL-13 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021373Orig1s013lbl.pdf | |
| 04/18/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21373lbl.pdf |
CHILDREN’S ADVIL COLD
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUSPENSION;ORAL; 100MG/5ML;15MG/5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN’S ADVIL COLD | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 100MG/5ML;15MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 021373 | GLAXOSMITHKLINE |
| CHILDREN’S MOTRIN COLD | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 100MG/5ML;15MG/5ML | SUSPENSION;ORAL | Over-the-counter | Yes | 021128 | J AND J CONSUMER INC |
| IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | 100MG/5ML;15MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 076478 | PERRIGO |
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