Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076359
Company: PERRIGO

Products on ANDA 076359

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076359

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.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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	HALEON US HOLDINGS