Orange Book product · Brand (NDA)
ISOVUE-370
IOPAMIDOL
At a glance
Dec 31, 1985
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 31, 1985
41 yr 1 mo ago
Today
Exclusivity ends · I-975
New indication exclusivity (3 years)
Oct 10, 2028
in 2 yr 4 mo
Pharmaceutical detail
Active ingredient
IOPAMIDOL
Strength
76%
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 018735
Product number
003
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.
- 1994ISOVUE-200Brand (NDA)
NDA 020327 · BRACCO
- 2023IOPAMIDOLGeneric (ANDA)
ANDA 217134 · HAINAN POLY
- 2023IOPAMIDOLGeneric (ANDA)
ANDA 215382 · HAINAN POLY
- 2010SCANLUX-300Generic (ANDA)
ANDA 090394 · SANOCHEMIA CORP USA
- 2000IOPAMIDOL-200Generic (ANDA)
ANDA 074881 · COOK IMAGING
- 1998IOPAMIDOL-250Generic (ANDA)
ANDA 075005 · HOSPIRA
- 1997IOPAMIDOL-200Generic (ANDA)
ANDA 074898 · HOSPIRA
- 1997IOPAMIDOL-200 IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 074636 · HOSPIRA
- 1997IOPAMIDOL-300Generic (ANDA)
ANDA 074638 · ABBVIE
- 1997IOPAMIDOL-300 IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 074637 · HOSPIRA
- 1997IOPAMIDOL-250Generic (ANDA)
ANDA 074679 · FRESENIUS KABI USA
- 1996IOPAMIDOLGeneric (ANDA)
ANDA 074734 · HOSPIRA
Marketing exclusivity (1)
- I-975New indication exclusivity (3 years)
Oct 10, 2028
in 2 yr 4 mo
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.
