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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 005010

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NDA 005010 describes DEMEROL, which is a drug marketed by Us Pharm Holdings and Hospira and is included in two NDAs. It is available from five 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. Twelve suppliers are listed for this compound. Additional details are available on the meperidine hydrochloride profile page.

Summary for NDA: 005010

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 005010

Mechanism of ActionFull Opioid Agonists

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 0024-0335-04 100 TABLET in 1 BOTTLE (0024-0335-04)
DEMEROL
meperidine hydrochloride
INJECTABLE;INJECTION 005010 NDA sanofi-aventis U.S. LLC 0024-0335 0024-0335-05 100 TABLET in 1 BOTTLE, PLASTIC (0024-0335-05)

Summary for product number 001

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

Summary for product number 002

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

Summary 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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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Novartis
Harvard Business School
Julphar
McKinsey
Deloitte
UBS
Baxter
McKesson
Covington

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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