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Details for New Drug Application (NDA): 019527

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NDA 019527 describes PEPCID, which is a drug marketed by Merck, Salix Pharms, Valeant Pharms North, J And J Consumer Inc, and Merck Sharp Dohme, and is included in nine NDAs. It is available from three suppliers. There are four patents protecting this drug and one Paragraph IV challenge. 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 fifty-three drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for NDA: 019527

Salix Pharms
Therapeutic Class:Gastrointestinal Agents

Pharmacology for NDA: 019527

Suppliers and Packaging for NDA: 019527

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOR SUSPENSION;ORAL 019527 NDA Paddock Laboratories, Inc. 0574-0147 0574-0147-04 50 mL in 1 BOTTLE (0574-0147-04)
FOR SUSPENSION;ORAL 019527 NDA Salix Pharmaceuticals, Inc. 65649-211 65649-211-24 50 mL in 1 BOTTLE (65649-211-24)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength40MG/5ML
Approval Date:Feb 2, 1987TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 019527

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix Pharms
FOR SUSPENSION;ORAL019527-001Feb 2, 19874,283,408*PED► subscribe
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