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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201803
Company: HALEON US HOLDINGS

Summary Review

Products on NDA 201803

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADVIL	IBUPROFEN SODIUM	EQ 200MG BASE	TABLET;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201803

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/2012	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201803Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201803s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201803_advil_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201803Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/08/2022	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201803Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201803Orig1s016ltr.pdf
05/31/2018	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201803Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201803Orig1s012ltr.pdf
04/12/2018	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201803Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201803Orig1s011ltr.pdf
08/22/2017	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201803Orig1s009ltr.pdf
06/12/2017	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201803Orig1s008ltr.pdf
06/03/2016	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201803Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201803Orig1s007ltr.pdf
11/05/2015	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/03/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/15/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 201803

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/08/2022	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201803Orig1s016lbl.pdf
05/31/2018	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201803Orig1s012lbl.pdf
04/12/2018	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201803Orig1s011lbl.pdf
08/22/2017	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s009lbl.pdf
06/12/2017	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201803Orig1s008lbl.pdf
06/03/2016	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201803Orig1s007lbl.pdf
06/12/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201803Orig1s000lbl.pdf

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

ADVIL

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

TABLET;ORAL; EQ 200MG BASE

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ADVIL	IBUPROFEN SODIUM	EQ 200MG BASE	TABLET;ORAL	Over-the-counter	Yes	201803	HALEON US HOLDINGS

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