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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 005010

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NDA 005010 describes DEMEROL, which is a drug marketed by Hospira and Us Pharm Holdings and is included in two NDAs. It is available from four suppliers. Additional details are available on the DEMEROL profile page.

The generic ingredient in DEMEROL is meperidine hydrochloride. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the meperidine hydrochloride profile page.
Summary for 005010
Tradename:DEMEROL
Applicant:Us Pharm Holdings
Ingredient:meperidine hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 005010
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 005010
Suppliers and Packaging for NDA: 005010
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEMEROL meperidine hydrochloride INJECTABLE;INJECTION 005010 NDA sanofi-aventis U.S. LLC 0024-0335 E 0024-0335-04
DEMEROL meperidine hydrochloride INJECTABLE;INJECTION 005010 NDA sanofi-aventis U.S. LLC 0024-0335 E 0024-0335-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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