Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074916
Company: P AND L

Products on ANDA 074916

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074916

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74916ta.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/13/2015	SUPPL-51	Labeling-Package Insert		Label is not available on this site.
03/03/2015	SUPPL-50	Labeling-Package Insert		Label is not available on this site.
12/16/2014	SUPPL-47	Labeling-Container/Carton Labels		Label is not available on this site.
11/26/2012	SUPPL-45	Labeling-Package Insert		Label is not available on this site.
05/13/2010	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
11/28/2007	SUPPL-27	Labeling		Label is not available on this site.
11/28/2007	SUPPL-25	Labeling		Label is not available on this site.
11/28/2007	SUPPL-23	Labeling		Label is not available on this site.
11/28/2007	SUPPL-21	Labeling		Label is not available on this site.
10/25/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
08/03/2001	SUPPL-5	Labeling		Label is not available on this site.
04/25/2001	SUPPL-4	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
01/29/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
01/29/2001	SUPPL-2	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
12/13/1999	SUPPL-1	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.

SUSPENSION;ORAL; 100MG/5ML

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CHILDREN'S ADVIL	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	020589	HALEON US HOLDINGS
CHILDREN'S ADVIL-FLAVORED	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	020589	HALEON US HOLDINGS
CHILDREN'S IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	074937	PERRIGO
CHILDREN'S MOTRIN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	Yes	020516	J AND J CONSUMER INC
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	210602	APTAPHARMA INC
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	209179	AUROBINDO PHARMA LTD
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	210149	GUARDIAN DRUG
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	074916	P AND L
IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION;ORAL	Over-the-counter	No	209207	TARO