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Details for New Drug Application (NDA): 011707

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NDA 011707 describes OPANA, which is a drug marketed by Endo Pharms and is included in four NDAs. It is available from seven suppliers. There are ten patents protecting this drug and six Paragraph IV challenges. Additional details are available on the OPANA profile page.

The generic ingredient in OPANA is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

Summary for NDA: 011707

Tradename:
OPANA
Applicant:
Endo Pharms
Ingredient:
oxymorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 011707

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 011707

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OPANA
oxymorphone hydrochloride
INJECTABLE;INJECTION 011707 NDA Endo Pharmaceuticals Inc. 63481-624 63481-624-10 10 AMPULE in 1 CARTON (63481-624-10) > 1 mL in 1 AMPULE (63481-624-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1.5MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes


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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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