Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019012
Company: J AND J CONSUMER INC
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
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-Container/Carton Labels, Labeling-Package Insert 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.cfm
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
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-Container/Carton Labels 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
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 No 018989 PFIZER
IBU-TAB 200 IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071057 ALRA
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 LTD
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 079174 GRANULES INDIA
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 202312 GRANULES INDIA LTD
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 070985 MERRO PHARM
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071163 OHM
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 070481 PAR PHARM
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 072096 PERRIGO
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 075995 PERRIGO
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 077349 PERRIGO R AND D
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 206990 SHANDONG XINHUA
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
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
IBUPROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 071639 VINTAGE PHARMS
MOTRIN IB IBUPROFEN 200MG TABLET;ORAL Over-the-counter Yes 019012 J AND J CONSUMER INC
TAB-PROFEN IBUPROFEN 200MG TABLET;ORAL Over-the-counter No 072095 PERRIGO

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.

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