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Last Updated: December 6, 2019

DrugPatentWatch Database Preview

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. Forty-six 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
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., McNeil Consumer Healthcare Division 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., McNeil Consumer Healthcare Division 50580-309 50580-309-02 1 BOTTLE in 1 CARTON (50580-309-02) > 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Paragraph IV (Patent) Challenges for 019872
Tradename Dosage Ingredient NDA Submissiondate
TYLENOL TABLET, EXTENDED RELEASE;ORAL acetaminophen 019872

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength650MG
Approval Date:Jun 8, 1994TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength650MG
Approval Date:Jan 11, 2001TE:RLD:Yes

Expired US Patents for NDA 019872

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

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