Product Details for ANDA 079046
OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE)
5MG
Marketing Status: Discontinued
7.5MG
Marketing Status: Discontinued
10MG
Marketing Status: Discontinued
15MG
Marketing Status: Discontinued
20MG
Marketing Status: Discontinued
30MG
Marketing Status: Discontinued
40MG
Marketing Status: Discontinued
5MG
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079046
Product Number: 003
Approval Date: Jul 11, 2013
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE)
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079046
Product Number: 003
Approval Date: Jul 11, 2013
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
7.5MG
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079046
Product Number: 001
Approval Date: Dec 13, 2010
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE)
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079046
Product Number: 001
Approval Date: Dec 13, 2010
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079046
Product Number: 004
Approval Date: Jul 11, 2013
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE)
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079046
Product Number: 004
Approval Date: Jul 11, 2013
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
15MG
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079046
Product Number: 002
Approval Date: Dec 13, 2010
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE)
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079046
Product Number: 002
Approval Date: Dec 13, 2010
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
20MG
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079046
Product Number: 005
Approval Date: Jul 11, 2013
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE)
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079046
Product Number: 005
Approval Date: Jul 11, 2013
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
30MG
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079046
Product Number: 006
Approval Date: Jul 11, 2013
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE)
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079046
Product Number: 006
Approval Date: Jul 11, 2013
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
40MG
Marketing Status: Discontinued
Active Ingredient: OXYMORPHONE HYDROCHLORIDE
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079046
Product Number: 007
Approval Date: Jul 11, 2013
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: OXYMORPHONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A079046
Product Number: 007
Approval Date: Jul 11, 2013
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information