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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021374
Company: HALEON US HOLDINGS

Products on NDA 021374

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADVIL COLD AND SINUS	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021374

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/30/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21374lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21374ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-374_Ibuprofen.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/19/2021	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021374orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021374Orig1s014ltr.pdf
03/24/2017	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021374Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021374Orig1s011ltr.pdf
03/14/2011	SUPPL-9	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021374s009ltr.pdf
05/19/2009	SUPPL-8	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021374s008ltr.pdf
06/23/2008	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021374s007ltr.pdf
12/07/2005	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021374s005ltr.pdf
04/17/2006	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021374s004ltr.pdf
10/17/2003	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21374SLR001_Advil_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21374SLR001ltr.pdf

Labels for NDA 021374

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/19/2021	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021374orig1s014lbl.pdf
03/24/2017	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021374Orig1s011lbl.pdf
10/17/2003	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21374SLR001_Advil_lbl.pdf
05/30/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21374lbl.pdf

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

ADVIL COLD AND SINUS

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

CAPSULE;ORAL; EQ 200MG FREE ACID AND POTASSIUM SALT;30MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ADVIL COLD AND SINUS	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE;ORAL	Over-the-counter	Yes	021374	HALEON US HOLDINGS
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE;ORAL	Over-the-counter	No	209235	AUROBINDO PHARMA

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