Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 200533

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NUCYNTA ER (TAPENTADOL HYDROCHLORIDE)
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)
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)
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)
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)
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