Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022321

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EMBEDA (MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE)
20MG;0.8MG
Marketing Status: Discontinued
Active Ingredient: MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Proprietary Name: EMBEDA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 20MG;0.8MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022321
Product Number: 001
Approval Date: Aug 13, 2009
Applicant Holder Full Name: ALPHARMA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EMBEDA (MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE)
30MG;1.2MG
Marketing Status: Discontinued
Active Ingredient: MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Proprietary Name: EMBEDA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 30MG;1.2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022321
Product Number: 002
Approval Date: Aug 13, 2009
Applicant Holder Full Name: ALPHARMA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EMBEDA (MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE)
50MG;2MG
Marketing Status: Discontinued
Active Ingredient: MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Proprietary Name: EMBEDA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 50MG;2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022321
Product Number: 003
Approval Date: Aug 13, 2009
Applicant Holder Full Name: ALPHARMA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EMBEDA (MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE)
60MG;2.4MG
Marketing Status: Discontinued
Active Ingredient: MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Proprietary Name: EMBEDA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG;2.4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022321
Product Number: 004
Approval Date: Aug 13, 2009
Applicant Holder Full Name: ALPHARMA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EMBEDA (MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE)
80MG;3.2MG
Marketing Status: Discontinued
Active Ingredient: MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Proprietary Name: EMBEDA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 80MG;3.2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022321
Product Number: 005
Approval Date: Aug 13, 2009
Applicant Holder Full Name: ALPHARMA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EMBEDA (MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE)
100MG;4MG
Marketing Status: Discontinued
Active Ingredient: MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Proprietary Name: EMBEDA
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG;4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022321
Product Number: 006
Approval Date: Aug 13, 2009
Applicant Holder Full Name: ALPHARMA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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