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Generated: August 22, 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, 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: 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 500+ biopharmaceutical companies globally:

US Army
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Covington
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Healthtrust

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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