Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019842
Company: MCNEIL CONSUMER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOTRIN IBUPROFEN 100MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUSPENSION;ORAL Discontinued None Yes No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
09/19/1989 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
09/10/2007 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019842s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019842s020ltr.pdf
01/24/2006 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019842s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019842s019ltr.pdf
05/14/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/18/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/2002 SUPPL-13 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019842s13,20135s5,20418s3,20476s2_MotrinTOC.cfm
02/22/1996 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/1996 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1995 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1995 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1994 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1995 SUPPL-4 Efficacy-New Indication

Label is not available on this site.

03/23/1993 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/10/2007 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019842s020lbl.pdf
01/24/2006 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019842s019lbl.pdf

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