Orange Book product · Brand (NDA)

ORACEA

DOXYCYCLINE

Brand (NDA)NDA 050805TE ABRX GALDERMA LABS LP

May 26, 2006

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 26, 2006
20 yr 4 mo ago
Today
Patent 7749532 expires
Listed drug product patent expiration.
Dec 19, 2027
in 1 yr 6 mo

Active ingredient

DOXYCYCLINE

Strength

40MG

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 050805

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
7749532	Dec 19, 2027	in 1 yr 6 mo	ProductU-1063