Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076359
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN IBUPROFEN 50MG TABLET, CHEWABLE;ORAL Discontinued None No No
IBUPROFEN IBUPROFEN 100MG TABLET, CHEWABLE;ORAL Over-the-counter None No 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
01/16/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76359ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/26/2012 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

01/21/2011 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

08/22/2008 SUPPL-22 Labeling

Label is not available on this site.

03/17/2006 SUPPL-15 Labeling

Label is not available on this site.

IBUPROFEN

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, CHEWABLE;ORAL; 100MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
IBUPROFEN IBUPROFEN 100MG TABLET, CHEWABLE;ORAL Over-the-counter No 076359 PERRIGO
JUNIOR STRENGTH ADVIL IBUPROFEN 100MG TABLET, CHEWABLE;ORAL Over-the-counter No 020944 PFIZER

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