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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203794

NUCYNTA (TAPENTADOL HYDROCHLORIDE)
EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TAPENTADOL HYDROCHLORIDE
Proprietary Name: NUCYNTA
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203794
Product Number: 001
Approval Date: Oct 15, 2012
Applicant Holder Full Name: COLLEGIUM PHARMACEUTICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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