Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020516
Company: J AND J CONSUMER INC
Company: J AND J CONSUMER INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN'S MOTRIN | IBUPROFEN | 100MG/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 06/16/1995 | 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 |
|---|---|---|---|---|---|
| 02/19/2021 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020516Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020516Orig1s038ltr.pdf | |
| 11/29/2018 | SUPPL-36 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020516Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020516Orig1s036ltr.pdf | |
| 03/14/2017 | SUPPL-35 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020516Orig1s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020516Orig1s035ltr.pdf | |
| 01/09/2017 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/2016 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020516Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020516Orig1s033ltr.pdf | |
| 06/17/2016 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/2015 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/2015 | SUPPL-30 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020516Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020516Orig1s030ltr.pdf | |
| 12/11/2014 | SUPPL-29 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020516Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020516Orig1s029ltr.pdf | |
| 11/19/2012 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/12/2012 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/2011 | SUPPL-24 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020516s024ltr.pdf |
| 10/19/2010 | SUPPL-22 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020516s022ltr.pdf |
| 04/29/2009 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020516s021ltr.pdf |
| 06/22/2006 | SUPPL-20 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020516s020LTR.pdf |
| 12/07/2005 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020516s018ltr.pdf |
| 02/07/2005 | SUPPL-16 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20516s016ltr.pdf |
| 12/19/2003 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20516slr012,21128slr003ltr.pdf |
| 10/28/2003 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19012slr034,20516slr011ltr.pdf |
| 05/02/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/18/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/13/1999 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) Review |
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 | |
| 12/18/1998 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/04/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/31/1997 | 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 |
|---|---|---|---|---|---|
| 02/19/2021 | SUPPL-38 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020516Orig1s038lbl.pdf | |
| 11/29/2018 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020516Orig1s036lbl.pdf | |
| 03/14/2017 | SUPPL-35 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020516Orig1s035lbl.pdf | |
| 03/14/2017 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020516Orig1s035lbl.pdf | |
| 06/16/2016 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020516Orig1s033lbl.pdf | |
| 04/16/2015 | SUPPL-30 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020516Orig1s030lbl.pdf | |
| 12/11/2014 | SUPPL-29 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020516Orig1s029lbl.pdf | |
| 09/13/1999 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-603S002_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;ORAL; 100MG/5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN'S ADVIL | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 020589 | HALEON US HOLDINGS |
| CHILDREN'S ADVIL-FLAVORED | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 020589 | HALEON US HOLDINGS |
| CHILDREN'S IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 074937 | PERRIGO |
| CHILDREN'S MOTRIN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | Yes | 020516 | J AND J CONSUMER INC |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 210602 | APTAPHARMA INC |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 209179 | AUROBINDO PHARMA LTD |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 210149 | GUARDIAN DRUG |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 074916 | P AND L |
| IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 209207 | TARO |