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Serving 500+ biopharmaceutical companies globally:

Cerilliant
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Generated: August 20, 2017

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 Novel Labs Inc, Mayne Pharma Inc, West-ward Pharms Int, Wes Pharma Inc, Vintage Pharms, Alvogen Malta, Ken Lifescience, Lannett Holdings Inc, Lehigh Valley, Actavis Elizabeth, Vistapharm, Amneal Pharms, Wockhardt Bio Ag, Mallinckrodt Inc, Sun Pharm Inds Inc, Aurolife Pharma Llc, Epic Pharma Llc, Avanthi Inc, Ani Pharms Inc, Nesher Pharms, Rhodes Pharms, Barr Labs Inc, and Watson Labs, and is included in thirty-six 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. Two suppliers are listed for this compound. Additional details are available on the ibuprofen; oxycodone hydrochloride profile page.

Summary for NDA: 200534

Tradename:
1
Applicant:
1
Ingredient:
1
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 63629-3763 63629-3763-1 60 CAPSULE in 1 BOTTLE (63629-3763-1)

Summary for product number 001

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


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