Orange Book product · Brand (NDA)

ALTRENO

TRETINOIN

Brand (NDA)NDA 209353RX DOW PHARM

Aug 23, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 23, 2018
7 yr 11 mo ago
Today
Patent 10653656 expires
Listed drug product patent expiration.
Aug 22, 2038
in 12 yr 4 mo
Patent 11324710 expires
Listed method-of-use patent (U-2368) expiration.
Aug 22, 2038
in 12 yr 4 mo

Active ingredient

TRETINOIN

Strength

0.05%

Dosage form

LOTION

Route

TOPICAL

TE code

Not listed

Application

NDA 209353

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
10653656	Aug 22, 2038	in 12 yr 4 mo	ProductU-2368
11324710	Aug 22, 2038	in 12 yr 4 mo	U-2368