Orange Book product · Brand (NDA)

DAPTOMYCIN

Brand (NDA)NDA 210282RX HOSPIRA

Jun 21, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 21, 2021
5 yr 1 mo ago
Today
Patent 10357535 expires
Listed drug product patent expiration.
Sep 11, 2033
in 7 yr 4 mo
Patent 9655946 expires
Listed drug product patent expiration.
Sep 11, 2033
in 7 yr 4 mo

Active ingredient

DAPTOMYCIN

Strength

500MG/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 210282

Product number

002

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
10357535	Sep 11, 2033	in 7 yr 4 mo	ProductU-3176
9655946	Sep 11, 2033	in 7 yr 4 mo	ProductU-3175