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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211733
Company: HALEON US HOLDINGS

Products on NDA 211733

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADVIL DUAL ACTION WITH ACETAMINOPHEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211733

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2020	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211733Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211733Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/211733Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/25/2022	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211733Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211733Orig1s004ltr.pdf
01/10/2022	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211733Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211733Orig1s003ltr.pdf

Labels for NDA 211733

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/25/2022	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211733Orig1s004lbl.pdf
01/10/2022	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211733Orig1s003lbl.pdf
02/28/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211733Orig1s000lbl.pdf

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

ADVIL DUAL ACTION WITH ACETAMINOPHEN

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

TABLET;ORAL; 250MG;125MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	No	218359	AUROBINDO PHARMA LTD
ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	No	216999	BIONPHARMA
ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	No	218247	DR REDDYS
ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	No	218311	GLENMARK PHARMS LTD
ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	No	216592	GRANULES
ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	No	214836	L PERRIGO CO
ACETAMINOPHEN AND IBUPROFEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	No	216994	MARKSANS PHARMA
ADVIL DUAL ACTION WITH ACETAMINOPHEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET;ORAL	Over-the-counter	Yes	211733	HALEON US HOLDINGS

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