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Cipla
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Teva
US Army
Cantor Fitzgerald
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Baxter

Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074597

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NDA 074597 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Akorn, Barr, Eurohlth Intl Sarl, Hospira, Hospira Inc, Watson Labs, Ascent Pharms Inc, West-ward Pharms Int, Actavis Labs Fl Inc, Osmotica, Paddock Llc, Aurolife Pharma Llc, Elite Labs, Lannett Co Inc, Nesher Pharms, and Specgx Llc, and is included in twenty NDAs. It is available from twenty-one suppliers. Additional details are available on the HYDROMORPHONE HYDROCHLORIDE profile page.

The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 074597
Tradename:HYDROMORPHONE HYDROCHLORIDE
Applicant:West-ward Pharms Int
Ingredient:hydromorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 074597
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 074597
Suppliers and Packaging for NDA: 074597
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 074597 ANDA West-Ward Pharmaceuticals Corp. 0054-0264 N 0054-0264-24
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 074597 ANDA West-Ward Pharmaceuticals Corp. 0054-0264 N 0054-0264-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Jul 29, 1998TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:May 29, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Merck
US Army
Baxter
Farmers Insurance
Moodys
Cerilliant
Daiichi Sankyo
Express Scripts

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