Orange Book product · Brand (NDA)

ALTABAX

RETAPAMULIN

Brand (NDA)NDA 022055DISCN ALMIRALL

Apr 12, 2007

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 12, 2007
19 yr 6 mo ago
Today
Patent 7875630 expires
Listed drug substance patent expiration.
Feb 14, 2027
in 8 mo

Active ingredient

RETAPAMULIN

Strength

Dosage form

OINTMENT

Route

TOPICAL

TE code

Not listed

Application

NDA 022055

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
7875630	Feb 14, 2027	in 8 mo	Substance