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 COLD AND SINUS از شرکت GLAXOSMITHKLINE
New Drug Application (NDA): 021374
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADVIL COLD AND SINUS | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 05/30/2002 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21374lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/24/2017 | SUPPL-11 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021374Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021374Orig1s011ltr.pdf |
||
| 03/14/2011 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021374s009ltr.pdf |
|
| 05/19/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021374s008ltr.pdf |
|
| 06/23/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021374s007ltr.pdf |
|
| 12/07/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021374s005ltr.pdf |
|
| 04/17/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021374s004ltr.pdf |
|
| 10/17/2003 | SUPPL-1 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21374SLR001_Advil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21374SLR001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/24/2017 | SUPPL-11 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021374Orig1s011lbl.pdf | |
| 10/17/2003 | SUPPL-1 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21374SLR001_Advil_lbl.pdf | |
| 05/30/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21374lbl.pdf |
ADVIL COLD AND SINUS
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE;ORAL; EQ 200MG FREE ACID AND POTASSIUM SALT;30MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ADVIL COLD AND SINUS | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE;ORAL | Over-the-counter | Yes | 021374 | GLAXOSMITHKLINE |
| IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE | EQ 200MG FREE ACID AND POTASSIUM SALT;30MG | CAPSULE;ORAL | Over-the-counter | No | 209235 | AUROBINDO PHARMA LTD |
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