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Last Updated: October 7, 2024

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 five suppliers. 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-three suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
Summary for 020958
Pharmacology for NDA: 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. 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. 16837-246 16837-246-50 50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-50)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength800MG;10MG;165MG
Approval Date:Oct 16, 2000TE:RLD:Yes

Expired US Patents for NDA 020958

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc PEPCID COMPLETE calcium carbonate; famotidine; magnesium hydroxide TABLET, CHEWABLE;ORAL 020958-001 Oct 16, 2000 ⤷  Sign Up ⤷  Sign Up
J And J Consumer Inc PEPCID COMPLETE calcium carbonate; famotidine; magnesium hydroxide TABLET, CHEWABLE;ORAL 020958-001 Oct 16, 2000 ⤷  Sign Up ⤷  Sign Up
J And J Consumer Inc PEPCID COMPLETE calcium carbonate; famotidine; magnesium hydroxide TABLET, CHEWABLE;ORAL 020958-001 Oct 16, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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