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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 021393

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NDA 021393 describes ADVIL PM, which is a drug marketed by Haleon Us Holdings and is included in two NDAs. It is available from three suppliers. Additional details are available on the ADVIL PM profile page.

The generic ingredient in ADVIL PM is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.

Summary for 021393

Tradename:	ADVIL PM
Applicant:	Haleon Us Holdings
Ingredient:	diphenhydramine hydrochloride; ibuprofen
Patents:	0

Pharmacology for NDA: 021393

Mechanism of Action	Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 021393

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393	NDA	Haleon US Holdings LLC	0573-0167	0573-0167-25	1 BOTTLE in 1 CARTON (0573-0167-25) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393	NDA	Haleon US Holdings LLC	0573-0167	0573-0167-26	1 BOTTLE in 1 CARTON (0573-0167-26) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE;ORAL			Strength	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date:	Dec 21, 2005	TE:		RLD:	Yes

Expired US Patents for NDA 021393

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005	⤷ Try a Trial	⤷ Try a Trial
Haleon Us Holdings	ADVIL PM	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	021393-001	Dec 21, 2005	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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