Orange Book product · Brand (NDA)
PRED-G
GENTAMICIN SULFATE; PREDNISOLONE ACETATE
At a glance
Jun 10, 1988
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 10, 1988
38 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
GENTAMICIN SULFATE; PREDNISOLONE ACETATE
Strength
EQ 0.3% BASE;1%
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 050586
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
