Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022304

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NUCYNTA (TAPENTADOL HYDROCHLORIDE)
EQ 50MG BASE
Marketing Status: Prescription

Active Ingredient: TAPENTADOL HYDROCHLORIDE
Proprietary Name: NUCYNTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022304
Product Number: 001
Approval Date: Nov 20, 2008
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NUCYNTA (TAPENTADOL HYDROCHLORIDE)
EQ 75MG BASE
Marketing Status: Prescription

Active Ingredient: TAPENTADOL HYDROCHLORIDE
Proprietary Name: NUCYNTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022304
Product Number: 002
Approval Date: Nov 20, 2008
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NUCYNTA (TAPENTADOL HYDROCHLORIDE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: TAPENTADOL HYDROCHLORIDE
Proprietary Name: NUCYNTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022304
Product Number: 003
Approval Date: Nov 20, 2008
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information