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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075217
Company: L PERRIGO CO

Products on ANDA 075217

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 075217

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-217_Ibuprofen_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75217ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-217_Ibuprofen.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/24/2011	SUPPL-38	Labeling-Container/Carton Labels		Label is not available on this site.
03/22/2006	SUPPL-26	Labeling		Label is not available on this site.
05/22/2003	SUPPL-9	Labeling		Label is not available on this site.
08/21/2001	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
06/14/2001	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/18/2000	SUPPL-4	Labeling		Label is not available on this site.
05/24/2000	SUPPL-3	Labeling		Label is not available on this site.
05/24/2000	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 075217

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-217_Ibuprofen_prntlbl.pdf

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

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