Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019012
Company: KENVUE BRANDS
Company: KENVUE BRANDS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MOTRIN IB | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | None | Yes | No |
| MOTRIN MIGRAINE PAIN | IBUPROFEN | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| NUPRIN | IBUPROFEN | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| NUPRIN | IBUPROFEN | 200MG | TABLET;ORAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 05/18/1984 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 11/16/2021 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Label for Motrin IB | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019012Orig1s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019012Orig1s059ltr.pdf |
| 01/07/2021 | SUPPL-58 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019012Orig1s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019012Orig1s058ltr.pdf | ||
| 03/16/2017 | SUPPL-57 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019012Orig1s056,s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019012Orig1s056,s057ltr.pdf | |
| 03/16/2017 | SUPPL-56 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019012Orig1s056,s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019012Orig1s056,s057ltr.pdf | |
| 08/18/2016 | SUPPL-55 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019012Orig1s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019012Orig1s055ltr.pdf | |
| 05/06/2016 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/2015 | SUPPL-53 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/019012Orig1s053.pdf |
| 03/11/2014 | SUPPL-52 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/019012Orig1s052.pdf |
| 03/28/2013 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/2012 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/2010 | SUPPL-46 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019012s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019012s046ltr.pdf | |
| 04/24/2009 | SUPPL-43 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019012s043ltr.pdf |
| 11/20/2007 | SUPPL-40 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019012s040_CKD.pdf |
| 12/08/2006 | SUPPL-38 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019012s038ltr.pdf |
| 02/08/2006 | SUPPL-37 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019012s037ltr.pdf |
| 10/28/2003 | SUPPL-34 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19012slr034,20516slr011ltr.pdf |
| 03/27/2002 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/2001 | SUPPL-28 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19012s28lbl.pdf | |
| 05/02/2001 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/05/2001 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/2001 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 03/22/2000 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/2000 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/21/1999 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/2000 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1999 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/25/2000 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/25/2000 | SUPPL-16 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-012S016_Ibuprofen_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19012S16LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-012S016.html | |
| 04/10/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1995 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/10/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/25/1994 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/17/1990 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1990 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/02/1990 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/1990 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1997 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 12/16/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1986 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/16/2021 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | Label for Motrin IB | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019012Orig1s059lbl.pdf |
| 01/07/2021 | SUPPL-58 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019012Orig1s058lbl.pdf | |
| 03/16/2017 | SUPPL-57 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019012Orig1s056,s057lbl.pdf | |
| 03/16/2017 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019012Orig1s056,s057lbl.pdf | |
| 03/16/2017 | SUPPL-56 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019012Orig1s056,s057lbl.pdf | |
| 08/18/2016 | SUPPL-55 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019012Orig1s055lbl.pdf | |
| 10/21/2010 | SUPPL-46 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019012s046lbl.pdf | |
| 09/07/2001 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19012s28lbl.pdf | |
| 02/25/2000 | SUPPL-16 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-012S016_Ibuprofen_prntlbl.pdf |
MOTRIN IB
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 200MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ADVIL | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | Yes | 018989 | HALEON US HOLDINGS |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 072299 | ADAPTIS |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 079233 | AMNEAL PHARMS |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 071333 | AMNEAL PHARMS NY |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 072199 | AMNEAL PHARMS NY |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 208865 | AUROBINDO PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 076460 | AVEMA PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 075661 | DR REDDYS |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 076117 | DR REDDYS LABS INC |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 202312 | GRANULES |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 079174 | GRANULES INDIA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 075010 | LNK |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 075139 | LNK |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 091237 | MARKSANS PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 091239 | MARKSANS PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 073019 | MCNEIL |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 072096 | PERRIGO |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 077349 | PERRIGO R AND D |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 071229 | PH HEALTH |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 207095 | SHANDONG XINHUA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 079129 | STRIDES PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 091355 | STRIDES PHARMA |
| MOTRIN IB | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | Yes | 019012 | KENVUE BRANDS |
MOTRIN MIGRAINE PAIN
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.
NUPRIN
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.