Orange Book product · Brand (NDA)

NUCYNTA

TAPENTADOL HYDROCHLORIDE

Brand (NDA)NDA 203794DISCN COLLEGIUM PHARM INC

View TAPENTADOL HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Oct 15, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Oct 15, 2012
13 yr 11 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Jul 03, 2026
in 14 d
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Jan 03, 2027
in 7 mo

Pharmaceutical detail

Active ingredient

TAPENTADOL HYDROCHLORIDE

Strength

EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 203794

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (2)

NPPNew patient population exclusivity (3 years)
Jul 03, 2026
in 14 d
PEDPediatric exclusivity (adds 6 months)
Jan 03, 2027
in 7 mo

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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