Orange Book product · Brand (NDA)

SYNDROS

DRONABINOL

Brand (NDA)NDA 205525DISCN WELLHOUSE PHARMA

Mar 23, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 23, 2017
9 yr 5 mo ago
Today
Patent 10265293 expires
Listed drug substance patent expiration.
Aug 06, 2028
in 2 yr 2 mo
Patent 11253472 expires
Listed drug substance patent expiration.
Aug 06, 2028
in 2 yr 2 mo
Patent 8222292 expires
Listed drug substance patent expiration.
Aug 06, 2028
in 2 yr 2 mo
Patent 9345771 expires
Listed drug substance patent expiration.
Aug 06, 2028
in 2 yr 2 mo

Active ingredient

DRONABINOL

Strength

5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 205525

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
10265293	Aug 06, 2028	in 2 yr 2 mo	SubstanceProduct
11253472	Aug 06, 2028	in 2 yr 2 mo	SubstanceProduct
8222292	Aug 06, 2028	in 2 yr 2 mo	SubstanceProduct
9345771	Aug 06, 2028	in 2 yr 2 mo	SubstanceProduct