Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 201655

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OPANA ER (OXYMORPHONE HYDROCHLORIDE)
5MG
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OPANA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N201655
Product Number: 001
Approval Date: Dec 9, 2011
Applicant Holder Full Name: ENDO PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
OPANA ER (OXYMORPHONE HYDROCHLORIDE)
7.5MG
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OPANA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 7.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N201655
Product Number: 002
Approval Date: Dec 9, 2011
Applicant Holder Full Name: ENDO PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
OPANA ER (OXYMORPHONE HYDROCHLORIDE)
10MG
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OPANA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N201655
Product Number: 003
Approval Date: Dec 9, 2011
Applicant Holder Full Name: ENDO PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
OPANA ER (OXYMORPHONE HYDROCHLORIDE)
15MG
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OPANA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N201655
Product Number: 004
Approval Date: Dec 9, 2011
Applicant Holder Full Name: ENDO PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
OPANA ER (OXYMORPHONE HYDROCHLORIDE)
20MG
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OPANA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N201655
Product Number: 005
Approval Date: Dec 9, 2011
Applicant Holder Full Name: ENDO PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
OPANA ER (OXYMORPHONE HYDROCHLORIDE)
30MG
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OPANA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N201655
Product Number: 006
Approval Date: Dec 9, 2011
Applicant Holder Full Name: ENDO PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
OPANA ER (OXYMORPHONE HYDROCHLORIDE)
40MG
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OPANA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N201655
Product Number: 007
Approval Date: Dec 9, 2011
Applicant Holder Full Name: ENDO PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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