Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021011

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ROXICODONE (OXYCODONE HYDROCHLORIDE)
5MG
Marketing Status: Prescription

Active Ingredient: OXYCODONE HYDROCHLORIDE
Proprietary Name: ROXICODONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021011
Product Number: 003
Approval Date: May 15, 2009
Applicant Holder Full Name: SPECGX LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ROXICODONE (OXYCODONE HYDROCHLORIDE)
15MG
Marketing Status: Prescription

Active Ingredient: OXYCODONE HYDROCHLORIDE
Proprietary Name: ROXICODONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021011
Product Number: 001
Approval Date: Aug 31, 2000
Applicant Holder Full Name: SPECGX LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ROXICODONE (OXYCODONE HYDROCHLORIDE)
30MG
Marketing Status: Prescription

Active Ingredient: OXYCODONE HYDROCHLORIDE
Proprietary Name: ROXICODONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021011
Product Number: 002
Approval Date: Aug 31, 2000
Applicant Holder Full Name: SPECGX LLC
Marketing Status:  Prescription
Patent and Exclusivity Information