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): 020603
Company: J AND J CONSUMER INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN’S MOTRIN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS;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 |
|---|---|---|---|---|---|---|---|
| 06/10/1996 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 03/16/2017 | SUPPL-22 | Labeling-Package Insert, Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020603Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020603Orig1s022ltr.pdf |
||
| 08/29/2016 | SUPPL-21 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020603Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020603Orig1s021ltr.pdf |
||
| 12/04/2015 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/2010 | SUPPL-14 | Labeling-Medication Guide |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020603s014ltr.pdf |
|
| 04/29/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020603s013ltr.pdf |
|
| 02/27/2006 | SUPPL-11 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020603s011ltr.pdf |
|
| 01/16/2002 | SUPPL-5 | Manufacturing (CMC)-Packaging |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20603s5lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20603s5ltr.pdf |
||
| 05/03/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/15/1999 | SUPPL-3 | Efficacy-New Patient Population |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S3_InfantsMotrin.pdf |
|
| 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 |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603S001_Ibuprofen_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603S001_Ibuprofen_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603s001_Ibuprofen.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/16/2017 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020603Orig1s022lbl.pdf | |
| 03/16/2017 | SUPPL-22 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020603Orig1s022lbl.pdf | |
| 08/29/2016 | SUPPL-21 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020603Orig1s021lbl.pdf | |
| 01/16/2002 | SUPPL-5 |
Manufacturing (CMC)-Packaging |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20603s5lbl.pdf | |
| 09/13/1999 | SUPPL-2 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_Ibuprofen_prntlbl.pdf | |
| 06/12/1998 | SUPPL-1 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-603S001_Ibuprofen_prntlbl.pdf |
CHILDREN’S MOTRIN
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUSPENSION/DROPS;ORAL; 40MG/ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN’S MOTRIN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS;ORAL | Over-the-counter | Yes | 020603 | J AND J CONSUMER INC |
| IBUPROFEN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS;ORAL | Over-the-counter | No | 210755 | GUARDIAN DRUG |
| IBUPROFEN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS;ORAL | Over-the-counter | No | 075217 | L PERRIGO CO |
| IBUPROFEN | IBUPROFEN | 40MG/ML | SUSPENSION/DROPS;ORAL | Over-the-counter | No | 079058 | TRIS PHARMA INC |
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