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Serving 500+ biopharmaceutical companies globally:

Medtronic
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Federal Trade Commission
Colorcon
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AstraZeneca

Generated: June 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202946

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NDA 202946 describes OXYMORPHONE HYDROCHLORIDE, which is a drug marketed by Avanthi Inc, Sun Pharm Inds Ltd, Mallinckrodt Inc, West-ward Pharms Int, Teva, Actavis Elizabeth, Aurolife Pharma Llc, Impax Labs, Epic Pharma Llc, and Par Pharm, and is included in twelve NDAs. It is available from eleven suppliers. Additional details are available on the OXYMORPHONE HYDROCHLORIDE profile page.

The generic ingredient in OXYMORPHONE HYDROCHLORIDE is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

Summary for NDA: 202946

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

Pharmacology for NDA: 202946

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 202946

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 202946 ANDA Mallinckrodt, Inc. 0406-8091 0406-8091-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-8091-01)
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 202946 ANDA Mallinckrodt, Inc. 0406-8092 0406-8092-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-8092-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Jun 27, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength7.5MG
Approval Date:Jun 27, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jun 27, 2014TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Chubb
McKesson
US Army
Farmers Insurance
McKinsey
Mallinckrodt
Colorcon
Queensland Health
Novartis

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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