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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
Harvard Business School
Queensland Health
Citi
Cipla
Cerilliant
Colorcon
Express Scripts
Baxter

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205629

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NDA 205629 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Akorn, Barr, 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, Mallinckrodt, and Nesher Pharms, and is included in nineteen NDAs. It is available from twenty 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-six suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 205629
Tradename:HYDROMORPHONE HYDROCHLORIDE
Applicant:Osmotica
Ingredient:hydromorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 205629
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 205629
Suppliers and Packaging for NDA: 205629
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205629 ANDA Trigen Laboratories, LLC 13811-701 13811-701-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-701-10)
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205629 ANDA Trigen Laboratories, LLC 13811-702 13811-702-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-702-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength8MG
Approval Date:Jul 7, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12MG
Approval Date:Jul 7, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength16MG
Approval Date:Jul 7, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

UBS
Merck
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Deloitte
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McKesson
Moodys
AstraZeneca
McKinsey

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