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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Fish and Richardson
Teva
Medtronic
Argus Health
Cipla
Daiichi Sankyo
Harvard Business School
Citi

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205814

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NDA 205814 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 205814
Tradename:HYDROMORPHONE HYDROCHLORIDE
Applicant:Aurolife Pharma Llc
Ingredient:hydromorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 205814
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 205814
Suppliers and Packaging for NDA: 205814
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 205814 ANDA Aurolife Pharma, LLC 13107-107 N 13107-107-01
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 205814 ANDA Aurolife Pharma, LLC 13107-107 N 13107-107-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:May 13, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:May 13, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:May 13, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
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Chinese Patent Office
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