Orange Book product · Brand (NDA)

TADLIQ

TADALAFIL

Brand (NDA)NDA 214522RX CMP DEV LLC

Jun 17, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 17, 2022
4 yr 1 mo ago
Today
Patent 11382917 expires
Listed drug product patent expiration.
Dec 24, 2038
in 12 yr 8 mo
Patent 11666576 expires
Listed drug product patent expiration.
Dec 24, 2038
in 12 yr 8 mo
Patent 11975006 expires
Listed drug product patent expiration.
Dec 24, 2038
in 12 yr 8 mo
Patent 12186322 expires
Listed drug product patent expiration.
Dec 24, 2038
in 12 yr 8 mo

Active ingredient

TADALAFIL

Strength

20MG/5ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 214522

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
11382917	Dec 24, 2038	in 12 yr 8 mo	ProductU-3397
11666576	Dec 24, 2038	in 12 yr 8 mo	ProductU-3397
11975006	Dec 24, 2038	in 12 yr 8 mo	ProductU-3397
12186322	Dec 24, 2038	in 12 yr 8 mo	ProductU-3397