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Last Updated: April 24, 2024

Details for New Drug Application (NDA): 019872

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NDA 019872 describes TYLENOL, which is a drug marketed by J And J Consumer Inc, Ortho Mcneil Pharm, and Janssen Pharms, and is included in seven NDAs. It is available from one supplier. Additional details are available on the TYLENOL profile page.

The generic ingredient in TYLENOL is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

Summary for 019872

Tradename:	TYLENOL
Applicant:	J And J Consumer Inc
Ingredient:	acetaminophen
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 019872

Analgesics, Non-Narcotic
Antipyretics

Suppliers and Packaging for NDA: 019872

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872	NDA	Johnson & Johnson Consumer Inc.	50580-309	50580-309-01	1 BOTTLE in 1 CARTON (50580-309-01) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872	NDA	Johnson & Johnson Consumer Inc.	50580-309	50580-309-02	1 BOTTLE in 1 CARTON (50580-309-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	650MG
Approval Date:	Jun 8, 1994	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	650MG
Approval Date:	Jan 11, 2001	TE:		RLD:	Yes

Expired US Patents for NDA 019872

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994	⤷ Try a Trial	⤷ Try a Trial
J And J Consumer Inc	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994	⤷ Try a Trial	⤷ Try a Trial
J And J Consumer Inc	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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