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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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US Department of Justice
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Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203208

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NDA 203208 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, Hi-tech Pharmacal, Ascent Pharms Inc, Ken Lifescience, Pharm Assoc, Lannett Holdings Inc, Lehigh Valley, Actavis Elizabeth, Vistapharm, Amneal Pharms, Ani Pharms Inc, Wockhardt Bio Ag, Mallinckrodt Inc, Sun Pharm Inds Inc, Aurolife Pharma Llc, Epic Pharma Llc, Avanthi Inc, Nesher Pharms, Rhodes Pharms, Abhai Llc, Barr Labs Inc, and Watson Labs, and is included in forty-three NDAs. It is available from fifty 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 NDA: 203208

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

Pharmacology for NDA: 203208

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 203208

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
SOLUTION;ORAL 203208 ANDA West-Ward Pharmaceuticals Corp. 0054-0393 0054-0393-44 30 mL in 1 BOTTLE (0054-0393-44)
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
SOLUTION;ORAL 203208 ANDA Atlantic Biologicals Corps 17856-0393 17856-0393-1 1 mL in 1 SYRINGE, PLASTIC (17856-0393-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/5ML
Approval Date:Jul 12, 2013TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Deloitte
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