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Serving leading biopharmaceutical companies globally:

Express Scripts
Colorcon
AstraZeneca
Cipla
Fuji
McKinsey
Citi
Cerilliant
Julphar
Covington

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200534

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NDA 200534 describes OXYCODONE HYDROCHLORIDE, which is a drug marketed by Ani Pharms Inc, Avanthi Inc, Lannett Holdings Inc, Lehigh Valley, Mayne Pharma Inc, Novel Labs Inc, Abhai Llc, Ascent Pharms Inc, Hi-tech Pharmacal, Pharm Assoc, Vistapharm, Wes Pharma Inc, West-ward Pharms Int, Wockhardt Bio Ag, Actavis Elizabeth, Alvogen Malta, Amneal Pharms, Aurolife Pharma Llc, Epic Pharma Llc, Ken Lifescience, Mallinckrodt Inc, Nesher Pharms, Rhodes Pharms, Sun Pharm Inds Inc, Vintage Pharms, Barr Labs Inc, and Watson Labs, and is included in forty-four NDAs. It is available from forty-eight suppliers. Additional details are available on the OXYCODONE HYDROCHLORIDE profile page.

The generic ingredient in OXYCODONE HYDROCHLORIDE is ibuprofen; oxycodone hydrochloride. There are sixty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibuprofen; oxycodone hydrochloride profile page.
Summary for 200534
Tradename:OXYCODONE HYDROCHLORIDE
Applicant:Lehigh Valley
Ingredient:oxycodone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 200534
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 200534
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride CAPSULE;ORAL 200534 NDA AUTHORIZED GENERIC American Health Packaging 60687-116 60687-116-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-116-21) > 1 CAPSULE in 1 BLISTER PACK (60687-116-11)
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride CAPSULE;ORAL 200534 NDA AUTHORIZED GENERIC Bryant Ranch Prepack 63629-3803 63629-3803-2 30 CAPSULE in 1 BOTTLE (63629-3803-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Oct 20, 2010TE:ABRLD:Yes

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
QuintilesIMS
Citi
Johnson and Johnson
Accenture
McKesson
Boehringer Ingelheim
US Department of Justice
AstraZeneca

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