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Last Updated: January 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020958

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NDA 020958 describes PEPCID COMPLETE, which is a drug marketed by J And J Consumer Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the PEPCID COMPLETE profile page.

The generic ingredient in PEPCID COMPLETE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
Summary for 020958
Suppliers and Packaging for NDA: 020958
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PEPCID COMPLETE calcium carbonate; famotidine; magnesium hydroxide TABLET, CHEWABLE;ORAL 020958 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 16837-246 16837-246-25 25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-25)
PEPCID COMPLETE calcium carbonate; famotidine; magnesium hydroxide TABLET, CHEWABLE;ORAL 020958 NDA Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 16837-246 16837-246-50 50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-50)
Paragraph IV (Patent) Challenges for 020958
Tradename Dosage Ingredient NDA Submissiondate
PEPCID COMPLETE TABLET, CHEWABLE;ORAL calcium carbonate; famotidine; magnesium hydroxide 020958 2004-11-01

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength800MG;10MG;165MG
Approval Date:Oct 16, 2000TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 26, 2022Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 020958

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Serving leading biopharmaceutical companies globally:

Dow
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Express Scripts
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