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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Chubb
US Army
Merck
Daiichi Sankyo
Harvard Business School
Moodys
Citi
Teva

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020325

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NDA 020325 describes PEPCID AC, which is a drug marketed by J And J Consumer Inc and is included in three NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the PEPCID AC profile page.

The generic ingredient in PEPCID AC is famotidine. There are eighteen drug master file entries for this compound. One hundred and six suppliers are listed for this compound. Additional details are available on the famotidine profile page.
Summary for 020325
Tradename:PEPCID AC
Applicant:J And J Consumer Inc
Ingredient:famotidine
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020325
Suppliers and Packaging for NDA: 020325
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PEPCID AC famotidine TABLET;ORAL 020325 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 16837-855 N 16837-855-67
PEPCID AC famotidine TABLET;ORAL 020325 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 16837-855 N 16837-855-49

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Apr 28, 1995TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength20MG
Approval Date:Sep 23, 2003TE:RLD:Yes

Expired US Patents for NDA 020325

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc PEPCID AC famotidine TABLET;ORAL 020325-001 Apr 28, 1995 ➤ Sign Up ➤ Sign Up
J And J Consumer Inc PEPCID AC famotidine TABLET;ORAL 020325-001 Apr 28, 1995 ➤ Sign Up ➤ Sign Up
J And J Consumer Inc PEPCID AC famotidine TABLET;ORAL 020325-001 Apr 28, 1995 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Colorcon
Boehringer Ingelheim
Harvard Business School
Accenture
Mallinckrodt
US Department of Justice
Argus Health
Moodys

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