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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021393
Company: HALEON US HOLDINGS

Products on NDA 021393

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADVIL PM	DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021393

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/2005	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021393,021394lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021393,021394ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021393,021394_AdvilTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/09/2024	SUPPL-22	Manufacturing (CMC)-Manufacturing Process	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021393Orig1s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021393Orig1s022ltr.pdf
01/11/2022	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021393Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021393Orig1s021ltr.pdf
05/07/2018	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/21393Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/21393Orig1s017ltr.pdf
03/29/2017	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021393Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021393Orig1s014ltr.pdf
02/04/2013	SUPPL-12	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021393Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021393Orig1s012ltr.pdf
04/20/2011	SUPPL-7	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021393s007ltr.pdf
05/19/2009	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021393s006ltr.pdf
06/11/2008	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021393s005ltr.pdf

Labels for NDA 021393

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/09/2024	SUPPL-22	Manufacturing (CMC)-Manufacturing Process	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021393Orig1s022lbl.pdf
01/11/2022	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021393Orig1s021lbl.pdf
05/07/2018	SUPPL-17	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/21393Orig1s017lbl.pdf
03/29/2017	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021393Orig1s014lbl.pdf
02/04/2013	SUPPL-12	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021393Orig1s012lbl.pdf
12/21/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021393,021394lbl.pdf

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

ADVIL PM

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

CAPSULE;ORAL; 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ADVIL PM	DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	Yes	021393	HALEON US HOLDINGS
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	No	210676	AUROBINDO PHARMA LTD
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	No	090397	BIONPHARMA
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE;ORAL	Over-the-counter	No	200888	STRIDES SOFTGELS

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