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Details for New Drug Application (NDA): 019462

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NDA 019462 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: 019462

Valeant Pharms North
Therapeutic Class:Gastrointestinal Agents

Pharmacology for NDA: 019462

Suppliers and Packaging for NDA: 019462

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 019462 NDA PD-Rx Pharmaceuticals, Inc. 55289-473 55289-473-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-473-06)
TABLET;ORAL 019462 NDA PD-Rx Pharmaceuticals, Inc. 55289-473 55289-473-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-473-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 15, 1986TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Oct 15, 1986TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 019462

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms North
TABLET;ORAL019462-001Oct 15, 19864,283,408*PED<subscribe>
Valeant Pharms North
TABLET;ORAL019462-002Oct 15, 19864,283,408*PED<subscribe>
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