Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205777

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TARGINIQ (NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE)
5MG;10MG
Marketing Status: Discontinued

Active Ingredient: NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Proprietary Name: TARGINIQ
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG;10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205777
Product Number: 001
Approval Date: Jul 23, 2014
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information

TARGINIQ (NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE)
10MG;20MG
Marketing Status: Discontinued

Active Ingredient: NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Proprietary Name: TARGINIQ
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG;20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205777
Product Number: 002
Approval Date: Jul 23, 2014
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information

TARGINIQ (NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE)
20MG;40MG
Marketing Status: Discontinued

Active Ingredient: NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
Proprietary Name: TARGINIQ
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 20MG;40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205777
Product Number: 003
Approval Date: Jul 23, 2014
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information