Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018989
Company: HALEON US HOLDINGS
Company: HALEON US HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADVIL | IBUPROFEN | 200MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 05/18/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/14/2021 | SUPPL-99 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018989Orig1s099lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018989Orig1s099ltr.pdf | |
| 04/10/2020 | SUPPL-95 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/14/2018 | SUPPL-91 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018989Orig1s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018989Orig1s091ltr.pdf | |
| 10/02/2018 | SUPPL-90 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018989Orig1s090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018989Orig1s090ltr.pdf | |
| 08/23/2017 | SUPPL-88 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018989Orig1s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018989Orig1s088ltr.pdf | |
| 02/03/2017 | SUPPL-87 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/2016 | SUPPL-85 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/2015 | SUPPL-84 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018989Orig1s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018989Orig1s084ltr.pdf | |
| 05/18/2015 | SUPPL-83 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/01/2010 | SUPPL-80 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018989s080ltr.pdf |
| 04/26/2011 | SUPPL-79 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018989Orig1s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018989s079ltr.pdf | |
| 05/19/2009 | SUPPL-73 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018989s073ltr.pdf |
| 06/11/2008 | SUPPL-70 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018989s070ltr.pdf |
| 05/01/2007 | SUPPL-67 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018989s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018989s067ltr.pdf | |
| 04/04/2006 | SUPPL-61 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018989s061ltr.pdf |
| 04/17/2006 | SUPPL-60 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018989s060ltr.pdf |
| 07/16/2004 | SUPPL-58 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18989s058ltr.pdf |
| 09/26/2003 | SUPPL-56 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18989scp056ltr.pdf | |
| 04/24/2002 | SUPPL-55 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18989scp056ltr.pdf | |
| 08/02/2001 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/07/2001 | SUPPL-53 | Manufacturing (CMC)-Control |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18989s53lbl.pdf | |
| 11/15/2000 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 10/04/1999 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1999 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/14/1998 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1996 | SUPPL-48 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/03/1996 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/1997 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/01/1995 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/1995 | SUPPL-42 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/07/1994 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1994 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/18/1993 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/1993 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1994 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 03/11/1994 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 08/24/1990 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/26/1993 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/1991 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1989 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1989 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/1991 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/02/1988 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/25/1988 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1988 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/06/1987 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1987 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1988 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/01/1988 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/25/1988 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/05/1986 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/24/1985 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/30/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1984 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/19/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/1984 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/14/2021 | SUPPL-99 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018989Orig1s099lbl.pdf | |
| 11/14/2018 | SUPPL-91 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018989Orig1s091lbl.pdf | |
| 10/02/2018 | SUPPL-90 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018989Orig1s090lbl.pdf | |
| 08/23/2017 | SUPPL-88 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018989Orig1s088lbl.pdf | |
| 12/16/2015 | SUPPL-84 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018989Orig1s084lbl.pdf |
| 04/26/2011 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018989Orig1s079lbl.pdf | |
| 05/01/2007 | SUPPL-67 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018989s067lbl.pdf | |
| 09/26/2003 | SUPPL-56 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf | |
| 04/24/2002 | SUPPL-55 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18989scp056_advil_lbl.pdf |
| 09/07/2001 | SUPPL-53 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18989s53lbl.pdf |
ADVIL
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 | 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 | 072299 | CONTRACT PHARMACAL |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 075661 | DR REDDYS LA |
| 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 | 207095 | SHANDONG XINHUA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 070481 | STRIDES PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 079129 | STRIDES PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 091355 | STRIDES PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 206989 | STRIDES PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 207052 | STRIDES PHARMA |
| IBUPROFEN | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | No | 071229 | VINTAGE PHARMS |
| MOTRIN IB | IBUPROFEN | 200MG | TABLET;ORAL | Over-the-counter | Yes | 019012 | J AND J CONSUMER INC |