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Details for New Drug Application (NDA): 020801

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NDA 020801 describes PEPCID AC, which is a drug marketed by J And J Consumer Inc and is included in three NDAs. It is available from two suppliers. There are three patents 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 nineteen suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the famotidine profile page.

Summary for NDA: 020801

J And J Consumer Inc
Therapeutic Class:Gastrointestinal Agents

Suppliers and Packaging for NDA: 020801

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET, CHEWABLE;ORAL 020801 NDA McNeil Consumer Pharmaceuticals Co. 16837-854 16837-854-02 1 TABLET, CHEWABLE in 1 POUCH (16837-854-02)
TABLET, CHEWABLE;ORAL 020801 NDA McNeil Consumer Pharmaceuticals Co. 16837-854 16837-854-04 2 CARTON in 1 PACKAGE (16837-854-04) > 1 BOTTLE in 1 CARTON (16837-854-50) > 50 TABLET, CHEWABLE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength10MG
Approval Date:Sep 24, 1998TE:RLD:No
Patent:5,667,794*PEDPatent Expiration:Nov 2, 2015Product Flag?Substance Flag?Delist Request?
Patent:5,854,267*PEDPatent Expiration:Jun 29, 2016Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength20MG
Approval Date:Dec 17, 2007TE:RLD:Yes
Patent:6,814,978*PEDPatent Expiration:Feb 26, 2022Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020801

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc
TABLET, CHEWABLE;ORAL020801-001Sep 24, 19984,283,408*PED<disabled>
J And J Consumer Inc
TABLET, CHEWABLE;ORAL020801-002Dec 17, 20075,075,114*PED<disabled>
J And J Consumer Inc
TABLET, CHEWABLE;ORAL020801-001Sep 24, 19985,667,794*PED<disabled>
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