Orange Book product · Brand (NDA)
GASTROGRAFIN
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
Strength
66%;10%
Dosage form
SOLUTION
Route
ORAL, RECTAL
TE code
AA
Application
NDA 011245
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.
- 1989MD-76RBrand (NDA)
NDA 019292 · LIEBEL-FLARSHEIM
- —HYPAQUE-M,75%Brand (NDA)
NDA 010220 · GE HEALTHCARE
- —RENOGRAFIN-60Brand (NDA)
NDA 010040 · BRACCO
- 2023DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUMGeneric (ANDA)
ANDA 215049 · ANNORA PHARMA
- 2022DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUMGeneric (ANDA)
ANDA 214201 · ANDA REPOSITORY
- 1988RENOCAL-76Generic (ANDA)
ANDA 089347 · BRACCO
- 1983DIATRIZOATE-60Generic (ANDA)
ANDA 088166 · INTL MEDICATION
- 1982ANGIOVIST 292Generic (ANDA)
ANDA 087724 · BAYER HLTHCARE
- 1982ANGIOVIST 370Generic (ANDA)
ANDA 087723 · BAYER HLTHCARE
- 1982GASTROVISTGeneric (ANDA)
ANDA 087728 · BAYER HLTHCARE
- —HYPAQUE-76Generic (ANDA)
ANDA 086505 · GE HEALTHCARE
- —MD-60Generic (ANDA)
ANDA 087074 · MALLINCKRODT
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.
