Orange Book product · Brand (NDA)

BONJESTA

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Brand (NDA)NDA 209661RX DUCHESNAY

Nov 07, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 07, 2016
9 yr 9 mo ago
Today
Patent 9089489 expires
Listed drug product patent expiration.
Feb 18, 2033
in 6 yr 9 mo
Patent 9375404 expires
Listed drug product patent expiration.
Feb 18, 2033
in 6 yr 9 mo
Patent 9526703 expires
Listed drug product patent expiration.
Feb 18, 2033
in 6 yr 9 mo
Patent 9937132 expires
Listed drug product patent expiration.
Feb 18, 2033
in 6 yr 9 mo

Active ingredient

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Strength

20MG;20MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 209661

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

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

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9089489	Feb 18, 2033	in 6 yr 9 mo	ProductU-1382
9375404	Feb 18, 2033	in 6 yr 9 mo	ProductU-1382
9526703	Feb 18, 2033	in 6 yr 9 mo	ProductU-1382
9937132	Feb 18, 2033	in 6 yr 9 mo	ProductU-1382