Product Details for NDA 200533
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE)
EQ 50MG BASE
Marketing Status: Prescription
EQ 100MG BASE
Marketing Status: Prescription
EQ 150MG BASE
Marketing Status: Prescription
EQ 200MG BASE
Marketing Status: Prescription
EQ 250MG BASE
Marketing Status: Prescription
EQ 50MG BASE
Marketing Status: Prescription
Active Ingredient: TAPENTADOL HYDROCHLORIDE
Proprietary Name: NUCYNTA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N200533
Product Number: 001
Approval Date: Aug 25, 2011
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE)
Proprietary Name: NUCYNTA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N200533
Product Number: 001
Approval Date: Aug 25, 2011
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 100MG BASE
Marketing Status: Prescription
Active Ingredient: TAPENTADOL HYDROCHLORIDE
Proprietary Name: NUCYNTA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N200533
Product Number: 002
Approval Date: Aug 25, 2011
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE)
Proprietary Name: NUCYNTA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N200533
Product Number: 002
Approval Date: Aug 25, 2011
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 150MG BASE
Marketing Status: Prescription
Active Ingredient: TAPENTADOL HYDROCHLORIDE
Proprietary Name: NUCYNTA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N200533
Product Number: 003
Approval Date: Aug 25, 2011
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE)
Proprietary Name: NUCYNTA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N200533
Product Number: 003
Approval Date: Aug 25, 2011
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 200MG BASE
Marketing Status: Prescription
Active Ingredient: TAPENTADOL HYDROCHLORIDE
Proprietary Name: NUCYNTA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N200533
Product Number: 004
Approval Date: Aug 25, 2011
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE)
Proprietary Name: NUCYNTA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N200533
Product Number: 004
Approval Date: Aug 25, 2011
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 250MG BASE
Marketing Status: Prescription
Active Ingredient: TAPENTADOL HYDROCHLORIDE
Proprietary Name: NUCYNTA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 250MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N200533
Product Number: 005
Approval Date: Aug 25, 2011
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: NUCYNTA ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 250MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N200533
Product Number: 005
Approval Date: Aug 25, 2011
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status: Prescription
Patent and Exclusivity Information