FDA Orange Book · active-ingredient family
Diatrizoate meglumine
Diatrizoate meglumine: 3 brands, 4 generics; first approved Sep 23, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
4
Listed patents
0
Presentations
14
Brand (NDA) products
Originator applications
- CYSTOGRAFINRLDBRACCONDA 010040—6 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30% INJECTABLE INJECTION Discontinued — 60% INJECTABLE INJECTION Discontinued — 76% INJECTABLE INJECTION Discontinued — 30% SOLUTION URETHRAL Rx — 30% SOLUTION URETERAL Discontinued — 18% SOLUTION URETHRAL Rx — - BRACCONDA 011620—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 85% INJECTABLE INJECTION Discontinued — - GE HEALTHCARENDA 016403—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60% INJECTABLE INJECTION Discontinued — 30% INJECTABLE INJECTION Discontinued — 30% SOLUTION URETHRAL Discontinued —
Generic (ANDA) products (4)
Abbreviated applications
- BAYER HLTHCAREANDA 0877261982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60% INJECTABLE INJECTION Discontinued — - BAYER HLTHCAREANDA 0877391982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30% INJECTABLE INJECTION Discontinued — - BAYER HLTHCAREANDA 0877291982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30% SOLUTION URETERAL Discontinued — - BAYER HLTHCAREANDA 0877311982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30% SOLUTION URETERAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
44 yr 7 mo ago
Most recent approval
44 yr 5 mo ago
All 7 applications were approved in 1982.
Brand (NDA) 343%
Generic (ANDA) 457%
Diatrizoate meglumine: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
