Orange Book product · Brand (NDA)
OMIDRIA
KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
At a glance
May 30, 2014
Approved
Brand (NDA)
Application
AT
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 30, 2014
12 yr 3 mo ago
Today
Patent 9066856 expires
Listed drug product patent expiration.
Oct 23, 2033
in 7 yr 5 mo
Patent 9486406 expires
Listed drug product patent expiration.
Oct 23, 2033
in 7 yr 5 mo
Patent 9855246 expires
Listed drug product patent expiration.
Oct 23, 2033
in 7 yr 5 mo
Patent 9066856*PED expires
Listed listed patent expiration.
Apr 23, 2034
in 8 yr
Patent 9486406*PED expires
Listed listed patent expiration.
Apr 23, 2034
in 8 yr
Pharmaceutical detail
Active ingredient
KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
Strength
EQ 0.3% BASE;EQ 1% BASE
Dosage form
SOLUTION
Route
IRRIGATION
TE code
AT
Application
NDA 205388
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 (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9066856 | Oct 23, 2033 | in 7 yr 5 mo | Product |
| 9486406 | Oct 23, 2033 | in 7 yr 5 mo | Product |
| 9855246 | Oct 23, 2033 | in 7 yr 5 mo | Product |
| 9066856*PED | Apr 23, 2034 | in 8 yr | |
| 9486406*PED | Apr 23, 2034 | in 8 yr |
