Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020135
Company: MCNEIL PED
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOTRIN IBUPROFEN 50MG TABLET, CHEWABLE;ORAL Discontinued None No No
MOTRIN IBUPROFEN 100MG TABLET, CHEWABLE;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
11/16/1994 ORIG-1 Approval Type 3 - New Dosage Form 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
08/05/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/2002 SUPPL-5 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20476s2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019842s13,20135s5,20418s3,20476s2_MotrinTOC.cfm
01/02/1996 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1995 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

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