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Last Updated: June 18, 2024

Details for New Drug Application (NDA): 019527

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NDA 019527 describes PEPCID, which is a drug marketed by Salix Pharms, Merck, Bausch, J And J Consumer Inc, and Merck Sharp Dohme, and is included in nine NDAs. It is available from one supplier. Additional details are available on the PEPCID profile page.

The generic ingredient in PEPCID 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 019527
Applicant:Salix Pharms
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 019527
Suppliers and Packaging for NDA: 019527
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PEPCID famotidine FOR SUSPENSION;ORAL 019527 NDA AUTHORIZED GENERIC Padagis US LLC 0574-0147 0574-0147-04 50 mL in 1 BOTTLE (0574-0147-04)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 2, 1987TE:RLD:Yes

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