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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021394
Company: HALEON US HOLDINGS

Products on NDA 021394

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADVIL PM	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET;ORAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021394

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
02/21/2023	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021394Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021394Orig1s033ltr.pdf
01/10/2022	SUPPL-32	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021394Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021394Orig1s032ltr.pdf
10/02/2018	SUPPL-26	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021394Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021394Orig1s026ltr.pdf
04/18/2018	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021394Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021394Orig1s025ltr.pdf
07/21/2017	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021394Orig1s023ltr.pdf
03/30/2017	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021394Orig1s021ltr.pdf
03/15/2016	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
01/05/2015	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
04/07/2015	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
09/01/2010	SUPPL-15	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021394s015ltr.pdf
04/25/2011	SUPPL-14	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021394s014ltr.pdf
05/19/2009	SUPPL-12	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021394s012ltr.pdf
06/11/2008	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021394s010ltr.pdf

Labels for NDA 021394

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2023	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021394Orig1s033lbl.pdf
01/10/2022	SUPPL-32	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021394Orig1s032lbl.pdf
10/02/2018	SUPPL-26	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021394Orig1s026lbl.pdf
04/18/2018	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021394Orig1s025lbl.pdf
07/21/2017	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s023lbl.pdf
03/30/2017	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021394Orig1s021lbl.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.

TABLET;ORAL; 38MG;200MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ADVIL PM	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET;ORAL	Over-the-counter	Yes	021394	HALEON US HOLDINGS
IBUPROFEN AND DIPHENHYDRAMINE CITRATE	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET;ORAL	Over-the-counter	No	216204	AUROBINDO PHARMA
IBUPROFEN AND DIPHENHYDRAMINE CITRATE	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET;ORAL	Over-the-counter	No	090619	DR REDDYS LABS LTD
IBUPROFEN AND DIPHENHYDRAMINE CITRATE	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET;ORAL	Over-the-counter	No	079113	PERRIGO R AND D
IBUPROFEN AND DIPHENHYDRAMINE CITRATE	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET;ORAL	Over-the-counter	No	211404	PLD ACQUISITIONS LLC

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