Orange Book product · Brand (NDA)
TEFLARO
CEFTAROLINE FOSAMIL
Brand (NDA)NDA 200327TE APRX ABBVIE
At a glance
Oct 29, 2010
Approved
Brand (NDA)
Application
AP
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 29, 2010
15 yr 10 mo ago
Today
Patent 9629861 expires
Listed drug product patent expiration.
Sep 21, 2030
in 4 yr 4 mo
Patent 8247400 expires
Listed drug product patent expiration.
Feb 10, 2031
in 4 yr 9 mo
Pharmaceutical detail
Active ingredient
CEFTAROLINE FOSAMIL
Strength
400MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
AP
Application
NDA 200327
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9629861 | Sep 21, 2030 | in 4 yr 4 mo | Product |
| 8247400 | Feb 10, 2031 | in 4 yr 9 mo | ProductU-282 |
