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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021610

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OPANA ER (OXYMORPHONE HYDROCHLORIDE)
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OPANA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021610
Product Number: 001
Approval Date: Jun 22, 2006
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
OPANA ER (OXYMORPHONE HYDROCHLORIDE)
7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OPANA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021610
Product Number: 005
Approval Date: Feb 29, 2008
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
OPANA ER (OXYMORPHONE HYDROCHLORIDE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OPANA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021610
Product Number: 002
Approval Date: Jun 22, 2006
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
OPANA ER (OXYMORPHONE HYDROCHLORIDE)
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OPANA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021610
Product Number: 006
Approval Date: Feb 29, 2008
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
OPANA ER (OXYMORPHONE HYDROCHLORIDE)
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OPANA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021610
Product Number: 003
Approval Date: Jun 22, 2006
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
OPANA ER (OXYMORPHONE HYDROCHLORIDE)
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OPANA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021610
Product Number: 007
Approval Date: Feb 29, 2008
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
OPANA ER (OXYMORPHONE HYDROCHLORIDE)
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OPANA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021610
Product Number: 004
Approval Date: Jun 22, 2006
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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