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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204085

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NDA 204085 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-three 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: 204085

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

Pharmacology for NDA: 204085

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 204085

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
SOLUTION;ORAL 204085 ANDA Lannett Company, Inc. 0527-1426 0527-1426-35 1 BOTTLE, PLASTIC in 1 CARTON (0527-1426-35) > 15 mL in 1 BOTTLE, PLASTIC
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
SOLUTION;ORAL 204085 ANDA Lannett Company, Inc. 0527-1426 0527-1426-36 1 BOTTLE, PLASTIC in 1 CARTON (0527-1426-36) > 30 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/5ML
Approval Date:Sep 9, 2014TE:AARLD:No


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Serving 500+ biopharmaceutical companies globally:

Citi
Baxter
Farmers Insurance
Queensland Health
UBS
Daiichi Sankyo
Mallinckrodt
Cipla
Express Scripts
Merck

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