Orange Book product · Brand (NDA)

VEREGEN

SINECATECHINS

Brand (NDA)NDA 021902RX ANI PHARMS

Oct 31, 2006

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 31, 2006
19 yr 11 mo ago
Today
Patent 7858662 expires
Listed drug product patent expiration.
Oct 02, 2026
in 4 mo

Active ingredient

SINECATECHINS

Strength

15%

Dosage form

OINTMENT

Route

TOPICAL

TE code

Not listed

Application

NDA 021902

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
7858662	Oct 02, 2026	in 4 mo	ProductU-172