Orange Book product · Generic (ANDA)
ROMIDEPSIN
ROMIDEPSIN
Generic (ANDA)ANDA 219099RX AMNEAL
At a glance
Jun 02, 2026
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 02, 2026
17 d ago
Today
Pharmaceutical detail
Active ingredient
ROMIDEPSIN
Strength
27.5MG/5.5ML (5MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 219099
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of ROMIDEPSIN
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.
