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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 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 twenty 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: 020325

Tradename:
PEPCID AC
Applicant:
J And J Consumer Inc
Ingredient:
famotidine
Patents:1
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

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 16837-855-05 1 BLISTER PACK in 1 CARTON (16837-855-05) > 5 TABLET, FILM COATED in 1 BLISTER PACK
PEPCID AC
famotidine
TABLET;ORAL 020325 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 16837-855 16837-855-09 1 BOTTLE, PLASTIC in 1 PACKAGE (16837-855-09) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength10MG
Approval Date:Apr 28, 1995TE:RLD:No
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;ORALStrength20MG
Approval Date:Sep 23, 2003TE:RLD:Yes

Expired Orange Book Patents for NDA: 020325

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc
PEPCID AC
famotidine
TABLET;ORAL020325-001Apr 28, 19954,283,408*PED► subscribe
J And J Consumer Inc
PEPCID AC
famotidine
TABLET;ORAL020325-001Apr 28, 19955,854,267*PED► subscribe
J And J Consumer Inc
PEPCID AC
famotidine
TABLET;ORAL020325-001Apr 28, 19955,667,794*PED► subscribe
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