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Fish and Richardson
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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091313

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NDA 091313 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-nine 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 091313

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 091313

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 091313

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 091313 ANDA Mylan Pharmaceuticals Inc. 0378-6112 0378-6112-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-6112-01)
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 091313 ANDA Mylan Pharmaceuticals Inc. 0378-6113 0378-6113-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-6113-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 18, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Feb 18, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Feb 18, 2011TE:ABRLD:No


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Queensland Health
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Chinese Patent Office
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