Orange Book product · Brand (NDA)

VANTRELA ER

HYDROCODONE BITARTRATE

Brand (NDA)NDA 207975DISCN TEVA BRANDED PHARM

Jan 17, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 17, 2017
9 yr 7 mo ago
Today
Patent 9216176 expires
Listed drug product patent expiration.
Sep 13, 2027
in 1 yr 3 mo
Patent 9572803 expires
Listed drug product patent expiration.
Sep 13, 2027
in 1 yr 3 mo
Patent 8445018 expires
Listed drug product patent expiration.
Jul 31, 2029
in 3 yr 2 mo

Active ingredient

HYDROCODONE BITARTRATE

Strength

15MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 207975

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
9216176	Sep 13, 2027	in 1 yr 3 mo	Product
9572803	Sep 13, 2027	in 1 yr 3 mo	Product
8445018	Jul 31, 2029	in 3 yr 2 mo	Product