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): 021393
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADVIL PM | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 05/07/2018 | SUPPL-17 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/21393Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/21393Orig1s017ltr.pdf |
||
| 03/29/2017 | SUPPL-14 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021393Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021393Orig1s014ltr.pdf |
||
| 02/04/2013 | SUPPL-12 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021393Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021393Orig1s012ltr.pdf |
||
| 04/20/2011 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021393s007ltr.pdf |
|
| 05/19/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021393s006ltr.pdf |
|
| 06/11/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021393s005ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/07/2018 | SUPPL-17 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/21393Orig1s017lbl.pdf | |
| 03/29/2017 | SUPPL-14 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021393Orig1s014lbl.pdf | |
| 02/04/2013 | SUPPL-12 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021393Orig1s012lbl.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.
CAPSULE;ORAL; 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ADVIL PM | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | Yes | 021393 | GLAXOSMITHKLINE |
| IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 210676 | AUROBINDO PHARMA LTD |
| IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 090397 | BIONPHARMA INC |
| IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 200888 | STRIDES PHARMA |
نظرات کاربران