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 PM از شرکت GLAXOSMITHKLINE
New Drug Application (NDA): 021394
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADVIL PM | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 38MG;200MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 12/21/2005 | ORIG-1 | Approval |
Type 4 – New Combination |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021393,021394lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/02/2018 | SUPPL-26 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021394Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021394Orig1s026ltr.pdf |
||
| 04/18/2018 | SUPPL-25 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021394Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021394Orig1s025ltr.pdf |
||
| 07/21/2017 | SUPPL-23 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021394Orig1s023ltr.pdf |
||
| 03/30/2017 | SUPPL-21 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021394Orig1s021ltr.pdf |
||
| 03/15/2016 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/2015 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2015 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/01/2010 | SUPPL-15 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021394s015ltr.pdf |
|
| 04/25/2011 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021394s014ltr.pdf |
|
| 05/19/2009 | SUPPL-12 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021394s012ltr.pdf |
|
| 06/11/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021394s010ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/02/2018 | SUPPL-26 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021394Orig1s026lbl.pdf | |
| 04/18/2018 | SUPPL-25 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021394Orig1s025lbl.pdf | |
| 07/21/2017 | SUPPL-23 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s023lbl.pdf | |
| 03/30/2017 | SUPPL-21 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s021lbl.pdf | |
| 12/21/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021393,021394lbl.pdf |
ADVIL PM
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 38MG;200MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ADVIL PM | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 38MG;200MG | TABLET;ORAL | Over-the-counter | Yes | 021394 | GLAXOSMITHKLINE |
| IBUPROFEN AND DIPHENHYDRAMINE CITRATE | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 38MG;200MG | TABLET;ORAL | Over-the-counter | No | 090619 | DR REDDYS LABS LTD |
| IBUPROFEN AND DIPHENHYDRAMINE CITRATE | DIPHENHYDRAMINE CITRATE; IBUPROFEN | 38MG;200MG | TABLET;ORAL | Over-the-counter | No | 079113 | PERRIGO R AND D |
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