Orange Book product · Brand (NDA)
COMPLERA
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Brand (NDA)NDA 202123TE ABRX GILEAD SCIENCES INC
At a glance
Aug 10, 2011
Approved
Brand (NDA)
Application
AB
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 10, 2011
15 yr 1 mo ago
Today
Patent 10857102 expires
Listed drug product patent expiration.
Jan 14, 2033
in 6 yr 8 mo
Pharmaceutical detail
Active ingredient
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Strength
200MG;EQ 25MG BASE;300MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 202123
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 (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10857102 | Jan 14, 2033 | in 6 yr 8 mo | Product |
