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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019842
Company: MCNEIL CONSUMER

Products on NDA 019842

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MOTRIN	IBUPROFEN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019842

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.

Labels for NDA 019842

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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