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Details for New Drug Application (NDA): 019510

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NDA 019510 describes PEPCID PRESERVATIVE FREE, which is a drug marketed by Merck and Merck Sharp Dohme and is included in two NDAs. Additional details are available on the PEPCID PRESERVATIVE FREE profile page.

The generic ingredient in PEPCID PRESERVATIVE FREE is famotidine. There are eighteen drug master file entries for this compound. One hundred and nineteen suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the famotidine profile page.

Summary for NDA: 019510

Therapeutic Class:Gastrointestinal Agents

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Nov 4, 1986TE:RLD:No

Summary for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Nov 4, 1986TE:RLD:No

Expired Orange Book Patents for NDA: 019510

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
INJECTABLE;INJECTION019510-001Nov 4, 19864,283,408*PED<subscribe>
INJECTABLE;INJECTION019510-004Nov 4, 19864,283,408*PED<subscribe>
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