Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079058
Company: TRIS PHARMA INC

Products on ANDA 079058

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079058

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/2009	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/10/2017	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
05/10/2017	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
05/10/2017	SUPPL-2	Labeling-Package Insert		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.

SUSPENSION/DROPS;ORAL; 40MG/ML

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CHILDREN'S MOTRIN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS;ORAL	Over-the-counter	Yes	020603	KENVUE BRANDS
IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS;ORAL	Over-the-counter	No	213506	AUROBINDO PHARMA LTD
IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS;ORAL	Over-the-counter	No	210755	GUARDIAN DRUG
IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS;ORAL	Over-the-counter	No	075217	L PERRIGO CO
IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS;ORAL	Over-the-counter	No	217261	SUN PHARMA CANADA
IBUPROFEN	IBUPROFEN	40MG/ML	SUSPENSION/DROPS;ORAL	Over-the-counter	No	079058	TRIS PHARMA INC