Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207621

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TROXYCA ER (NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE)
1.2MG;10MG
Marketing Status: Discontinued
Active Ingredient: NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Proprietary Name: TROXYCA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 1.2MG;10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N207621
Product Number: 001
Approval Date: Aug 19, 2016
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TROXYCA ER (NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE)
2.4MG;20MG
Marketing Status: Discontinued
Active Ingredient: NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Proprietary Name: TROXYCA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 2.4MG;20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N207621
Product Number: 002
Approval Date: Aug 19, 2016
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TROXYCA ER (NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE)
3.6MG;30MG
Marketing Status: Discontinued
Active Ingredient: NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Proprietary Name: TROXYCA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 3.6MG;30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N207621
Product Number: 003
Approval Date: Aug 19, 2016
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TROXYCA ER (NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE)
4.8MG;40MG
Marketing Status: Discontinued
Active Ingredient: NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Proprietary Name: TROXYCA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 4.8MG;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N207621
Product Number: 004
Approval Date: Aug 19, 2016
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TROXYCA ER (NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE)
7.2MG;60MG
Marketing Status: Discontinued
Active Ingredient: NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Proprietary Name: TROXYCA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 7.2MG;60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N207621
Product Number: 005
Approval Date: Aug 19, 2016
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
TROXYCA ER (NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE)
9.6MG;80MG
Marketing Status: Discontinued
Active Ingredient: NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Proprietary Name: TROXYCA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 9.6MG;80MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N207621
Product Number: 006
Approval Date: Aug 19, 2016
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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