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 MOTRIN از شرکت J AND J CONSUMER INC
New Drug Application (NDA): 020601
Company: J AND J CONSUMER INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN’S MOTRIN | IBUPROFEN | 50MG | TABLET, CHEWABLE;ORAL | Discontinued |
None |
Yes | No |
| JUNIOR STRENGTH MOTRIN | IBUPROFEN | 100MG | TABLET, CHEWABLE;ORAL | Discontinued |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 11/15/1996 | ORIG-1 | Approval |
Type 8 – Partial Rx to OTC Switch |
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 |
|---|---|---|---|---|---|
| 10/02/2018 | SUPPL-21 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020601Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020601Orig1s021ltr.pdf |
||
| 05/15/2017 | SUPPL-20 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020601Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020601Orig1s020ltr.pdf |
||
| 10/18/2010 | SUPPL-18 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020601s018ltr.pdf |
|
| 04/28/2009 | SUPPL-17 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020601s017ltr.pdf |
|
| 05/10/2006 | SUPPL-14 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020601s014ltr.pdf |
|
| 02/27/2006 | SUPPL-13 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020601s013ltr.pdf |
|
| 08/05/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/02/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/29/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/29/1999 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/18/1998 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/13/1999 | SUPPL-2 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603s002_Ibuprofen.cfm |
||
| 06/12/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/02/2018 | SUPPL-21 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020601Orig1s021lbl.pdf | |
| 05/15/2017 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020601Orig1s020lbl.pdf | |
| 09/13/1999 | SUPPL-2 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf |
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