Product Details for NDA 208090
XTAMPZA ER (OXYCODONE)
9MG
Marketing Status: Prescription
13.5MG
Marketing Status: Prescription
18MG
Marketing Status: Prescription
27MG
Marketing Status: Prescription
36MG
Marketing Status: Prescription
9MG
Marketing Status: Prescription
Active Ingredient: OXYCODONE
Proprietary Name: XTAMPZA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 9MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208090
Product Number: 001
Approval Date: Apr 26, 2016
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
XTAMPZA ER (OXYCODONE)
Proprietary Name: XTAMPZA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 9MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208090
Product Number: 001
Approval Date: Apr 26, 2016
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
13.5MG
Marketing Status: Prescription
Active Ingredient: OXYCODONE
Proprietary Name: XTAMPZA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 13.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208090
Product Number: 002
Approval Date: Apr 26, 2016
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
XTAMPZA ER (OXYCODONE)
Proprietary Name: XTAMPZA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 13.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208090
Product Number: 002
Approval Date: Apr 26, 2016
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
18MG
Marketing Status: Prescription
Active Ingredient: OXYCODONE
Proprietary Name: XTAMPZA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 18MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208090
Product Number: 003
Approval Date: Apr 26, 2016
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
XTAMPZA ER (OXYCODONE)
Proprietary Name: XTAMPZA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 18MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208090
Product Number: 003
Approval Date: Apr 26, 2016
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
27MG
Marketing Status: Prescription
Active Ingredient: OXYCODONE
Proprietary Name: XTAMPZA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 27MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208090
Product Number: 004
Approval Date: Apr 26, 2016
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
XTAMPZA ER (OXYCODONE)
Proprietary Name: XTAMPZA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 27MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208090
Product Number: 004
Approval Date: Apr 26, 2016
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
36MG
Marketing Status: Prescription
Active Ingredient: OXYCODONE
Proprietary Name: XTAMPZA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 36MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N208090
Product Number: 005
Approval Date: Apr 26, 2016
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: XTAMPZA ER
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 36MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N208090
Product Number: 005
Approval Date: Apr 26, 2016
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information