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Argus Health
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Cantor Fitzgerald
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Cerilliant
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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040331

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NDA 040331 describes MEPERIDINE HYDROCHLORIDE, which is a drug marketed by Abbott, Baxter Hlthcare, Igi Labs Inc, Intl Medication, Parke Davis, Watson Labs, West-ward Pharms Int, Barr, Duramed Pharms Barr, Epic Pharma, Mikart, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Vintage Pharms, Wyeth Ayerst, Hospira, and Icu Medical Inc, and is included in forty-two NDAs. It is available from seven suppliers. Additional details are available on the MEPERIDINE HYDROCHLORIDE profile page.

The generic ingredient in MEPERIDINE HYDROCHLORIDE is meperidine hydrochloride. There are six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the meperidine hydrochloride profile page.
Summary for 040331
Tradename:MEPERIDINE HYDROCHLORIDE
Applicant:Epic Pharma
Ingredient:meperidine hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 040331
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 040331
Suppliers and Packaging for NDA: 040331
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEPERIDINE HYDROCHLORIDE meperidine hydrochloride TABLET;ORAL 040331 ANDA Epic Pharma, LLC 42806-050 N 42806-050-01
MEPERIDINE HYDROCHLORIDE meperidine hydrochloride TABLET;ORAL 040331 ANDA Epic Pharma, LLC 42806-051 N 42806-051-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 28, 1999TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:May 28, 1999TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
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US Army
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Dow
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McKesson
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Teva

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